Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Hot Flashes

Breast Diseases

Skin Diseases

Quality of Life

All Drugs and Chemicals

Antihypertensive Agents

Analgesics

Urological Agents

Aromatase Inhibitors

Clonidine

Solifenacin Succinate

Sympatholytics

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Muscarinic Antagonists

Cholinergic Antagonists

Cholinergic Agents

oral solifenacin 5.0 mg daily for 3 weeks

solifenacin

Allen C Sherman, PhD

Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).

There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy

to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine

to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine

to evaluate changes in daily functioning (Hot Flash-Related Daily Interference Score) for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine

to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)

University of Arkansas

Rare Diseases

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

Bone Density Conservation Agents

Glucagon

Calcium

Calcium, Dietary

Glucagon-Like Peptide 1

Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones called cateholamines (epinephrine and norepinephrine). High levels of catecholamines can result in high blood pressure, headaches, sweating, heart palpitations, nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high enough to cause a stroke or heart attack in patients.

This study is designed to take patients suspected of having pheochromocytoma and confirm the diagnosis. This will be done using a variety of laboratory tests including a clonidine suppression test and glucagon stimulation test. These tests use drugs that can stimulate or reduce the activity of the tumor if it is present in the body.

Once a diagnosis is confirmed, patients participating in this study will undergo standard procedures to find the exact location of the tumor and receive standard therapy for the condition.

Patients suspected of having a pheochromocytoma will be studied via a series of tests in an attempt to ascertain biochemically whether or not they really have such a tumor. These procedures will include a standard clonidine suppression test and a standard glucagon stimulation test. Once the diagnosis has been made on the basis of biochemistry, then localization and therapy will be done via standard procedures. Measurement of plasma metanephrines on mailed samples is available for physicians who seek further evidence for the diagnosis of pheochromocytoma.

Diagnosis and Treatment of Pheochromocytoma

National Heart, Lung, and Blood Institute (NHLBI)

Mouth and Tooth Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Oral Ulcer

Oropharyngeal Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Placebo Mucoadhesive Buccal Tablet given daily during chemoradiotherapy

Clonidine HCl MBT given daily during chemoradiotherapy

Clonidine HCl Mucoadhesive Buccal Tablet

Placebo Mucoadhesive Buccal Tablet

Holli Carlson

This study is being performed to evaluate the effectiveness of a new drug, clonidine HCl MBT, to prevent the onset of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) who are being treated with chemoradiotherapy. OPC occurs on the back of the tongue or throat and is often treated by the use of chemoradiotherapy, where radiation is localized to these areas. Radiation to the OPC affected tissues causes the release of small proteins called cytokines that cause damage to the area surrounding the tumor including the oral cavity. This damage is characterized by the formation of mucositis which includes redness, pain and ulcers in the mouth and back of the throat. In addition, as more chemoradiation is administered to treat OPC, the inability to eat a solid diet (a Grade 3 mucositis) or to consume anything at all by mouth (a Grade 4 mucositis) occurs in many patients. Collectively, Grade 3 and Grade 4 mucositis is referred to as SOM. It is a frequent, debilitating side effect of chemoradiation in OPC that may cause patients to stop or interrupt their treatment, develop other side effects like the inability to swallow, or require the increased use of pain medications. OPC survivors who have successful treatment of their tumors often develop permanent swallowing, speaking and range of motion issues that may be linked back to the inability to eat and/or drink caused by SOM during their chemoradiotherapy treatment. Clonidine may inhibit the production of cytokines that cause SOM and clonidine HCl mucoadhesive buccal tablet (MBT) has been designed to deliver sustained high levels of clonidine in the oral cavity, potentially decreasing cytokine production and leading to a decrease in the incidence of SOM. Clonidine HCl MBT is a once per day treatment provided as a tablet that a patient may self-administer to the gums, where it sticks tightly to release clonidine over many hours. The primary objective of this Phase 2b/3 study is to evaluate whether clonidine HCl MBT is more effective than placebo MBT in decreasing the incidence of SOM.

This is a sequential design Phase 2b/3 multicenter, randomized (1:1), double-blind, placebo-controlled, parallel group study to compare the efficacy and safety of clonidine HCl MBT to placebo MBT in the prevention of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) undergoing chemoradiotherapy (CRT). Best supportive care (BSC) will be allowed as per individual institutional practice with some exceptions as described in the inclusion and exclusion criteria. Eligible patients will be randomized to receive either clonidine MBT or placebo. Patients will be centrally randomized in a 1:1 ratio. The randomization will be stratified by p16 status (positive or negative). Randomized patients will be required to self-apply the study drug to the gum once a day in addition to BSC. The first application of MBT study drug will be performed on Day 1 of the CRT regimen. Each site will require the patient to follow the same local practice for BSC per Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) guidelines with some exceptions as described in the inclusion and exclusion criteria. Daily, self-administered MBT study drug will be continued once daily for the entire duration of CRT treatment; defined as from Day 1 of CRT until the last day of CRT (anticipated to be approximately 4-8 weeks depending on the patient's prescribed CRT plan). Patients will be recruited sequentially into either the Phase 2b or the Phase 3 part of the study. An interim analysis will be conducted when Phase 2b patients have either completed their CRT or discontinued from the study. The Data Monitoring Committee (DMC) will review the Phase 2b efficacy and safety data at the interim analysis and will make a recommendation on proceeding with the Phase 3 part of the study.

Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.

A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Mucoadhesive Buccal Tablet to Placebo to Prevent Chemoradiotherapy-induced Severe Oral Mucositis in Patients With Oropharyngeal Cancer

The occurrence of SOM (Yes/No), defined as any reporting of World Health Organization (WHO) Grade 3-4 OM, from the first day to the last day of CRT. The WHO mucositis grading scale will be used to assess the occurrence of SOM in this trial. The WHO grading scale grades OM from 0 to 4 according to severity of clinical observation and functional limitation, with Grade 4 = oral alimentation impossible, Grade 3 = Oral ulcers, liquid diet only, Grade 2 = Oral erythema, ulcers, solid diet tolerated, Grade 1 = Oral soreness, erythema, and Grade 0 = normal, no mucositis (no signs, no symptoms).

Evaluate the safety and tolerability of administering HCl MBT to OPC patients receiving CRT by assessing the number and severity of treatment-emergent adverse events (TEAE) and specifically those TEAEs of special interest. Adverse events are graded and tabulated using NCI CTCAE v5.0.

Monopar Therapeutics

Central Nervous System Depressants

Pharmaceutical Solutions

Anti-Inflammatory Agents

Antirheumatic Agents

Ropivacaine

Diclofenac

Pirinitramide

Anesthetics

Anesthetics, Local

A "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml will be injected to the patients prior surgery. 10 ml of the drug combination will be injected between pectoral muscles and 20 ml of the drug combination will be injected between the muscles pectoralis minor and serratus anterior.

After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery.

A "pecs block" of Placebo (Sodium Chloride 0.9%) will be injected to the patients prior surgery. 10 ml of the Sodium chloride solution will be injected between pectoral muscles and 20 ml of the Sodium chloride solution will be injected between the muscles pectoralis minor and serratus anterior).

After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery.

Sodium Chloride

Maurice Sosnowski, MD

Kathleen Wiams, MD

The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).

This is a double-blind study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of 10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm A) versus 10 ml of placebo (NaCl 0.9%) injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm B). The pecs block will inject just before the surgery.

Subjects will receive a nausea and vomiting prophylaxy depending on Apfel score After surgery, the two intervention groups will receive before waking a dose of Paracetamol (1 g) and Diclofenac (75 mg), if they present no contraindications and a dose of 0.05 mg/kg Piritramide .

In the recovery room the two groups will benefit from a Patient Controlled Intravenous Analgesia (PCIA) pump - Piritramide allowing them to control their analgesia, which will be stopped at 24 hours postoperatively.

Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption

A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption

Piritramide consumption in the first 24 h post-surgery will be recorded

Pain intensity until 6 months post-surgery will be evaluated using the Short version of Mc Gill questionnaire (SF-MPQ2)

Present pain intensity until 48 hrs post- surgery will be assessed by Visual Analog scoring

Jules Bordet Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Antineoplastic Agents

Antiemetics

Vasoconstrictor Agents

Respiratory System Agents

Dexamethasone

Propofol

Epinephrine

Dexamethasone acetate

BB 1101

Racepinephrine

Epinephryl borate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.

Study staff calls participant about 3 days after surgery.

Participants receive general anesthesia (GA) during surgery without a caudal nerve block.

Study staff calls participant about 3 days after surgery.

General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg.

Caudal Nerve Block (CNB)

Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.

Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.

Decadron 10 mg by bolus injection given by anesthesiologist in OR.

Decadron

Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.

General anesthesia given in the OR using Propofol titrated for induction.

Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.

Phone Call

Bobby Bellard, MD

During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs.

The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery.

This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work.

Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups and CNB Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.

* If you are assigned to Group 1, you will receive a CNB and general anesthesia during surgery.
* If you are assigned to Group 2, you will only receive general anesthesia during surgery.

You will not know to which group you have been assigned. The CNB will be given to you while you are under general anesthesia. To receive a CNB, a special needle is inserted at the lower part of the back (near the tailbone). A type of local anesthesia is then injected into the sac surrounding the spinal cord that contains the nerves related to the penis.

All participants will also receive general anesthesia as part of their standard care. You will also receive a separate consent form for the surgery that explains the procedure and its risks, including the risks for general anesthesia.

After Surgery Data Collection:

During the 24 hours after surgery, the study staff will ask you to rate your pain on a scale of 0-10. You will be asked to rate your pain about every 30 minutes while you are in the hospital, but you may be asked to rate your pain more often if needed. It should take less than 5 minutes each time to rate your pain. Depending on how you rate your pain, additional pain drugs may be given to you as part of your standard care.

If you are discharged from the hospital on the same day as your surgery or if you are discharged before a member of the staff can ask you to rate your pain, the study staff will call you within 24 hours after you have been discharged from the hospital. This call should last about 5-10 minutes.

The amount of pain drugs given to you before, during, and after surgery will also be recorded.

About 3 days after your surgery, the study staff will call you to ask about your pain, the amount of pain drugs you have taken, and how satisfied you are with the type of anesthesia and pain control you have received. This call should last about 5-10 minutes.

Length of Study:

Your participation in this study will be over after the phone call about 3 days after your surgery has been completed.

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery

Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain.

To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate postoperative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score. The mean, median and max pain will be assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10. The NRS will be used verbally. Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'

To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in a decreased length of hospital stay compared with patients having only general anesthesia.

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.

General Anesthesia and Caudal Nerve Block

Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients	NCT01530373	Hot Flashes Breast Cancer	solifenacin Clonidine	18 Years -	University of Arkansas
Diagnosis and Treatment of Pheochromocytoma	NCT00001229	Pheochromocytom...		-	National Institutes of Health Clinical Center (CC)
Diagnosis and Treatment of Pheochromocytoma	NCT00001229	Pheochromocytom...		-	National Institutes of Health Clinical Center (CC)
Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.	NCT04648020	Chemoradiothera...	Clonidine HCl M... Placebo Mucoadh...	18 Years -	Monopar Therapeutics
Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption	NCT02655965	Locoregional An...	Ropivacaine Clonidine Sodium Chloride	18 Years -	Jules Bordet Institute
Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis	NCT02740127	Malignant Neopl...	Caudal Nerve Bl... Ropivacaine Epinephrine Decadron Clonidine Propofol Phone Call	18 Years -	M.D. Anderson Cancer Center
Diagnosis and Treatment of Pheochromocytoma	NCT00001229	Pheochromocytom...		-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for clonidine

Every month we try and update this database with for clonidine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for clonidine

Every month we try and update this database with for clonidine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for clonidine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.