Neoplasms

All Conditions

Digestive System Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Head and Neck Neoplasms

Mucositis

Ototoxicity

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Neuroprotective Agents

Gastrointestinal Agents

Herbal and Botanical

Ethanol

Cisplatin

Tempol

TEMPO

Aluminum hydroxide, magnesium hydroxide, simethicone drug combination

Antioxidants

Protective Agents

Enzyme Inhibitors

Radiation-Protective Agents

Orange

Peppermint

Patients will take 1000 mg of Tempol a day for the duration of radiation treatment (6-8 weeks)

Patients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks)

Investigational product is Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) oral solution. Tempol solution is an orange-colored, aqueous solution containing 7% Tempol along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils.

The placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching.

Placebo Solution

Benji Crane

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.

One hundred and twenty (120) participants with head and neck cancer are scheduled to undergo combined radio- and chemotherapy (n = 120).

Nearly all (90% to 97%) participants receiving radiotherapy in the head and neck will develop some degree of mucositis. Of these participants treated with radiotherapy with or without chemotherapy, 34% to 43% will present severe mucositis. As a result, the participant's quality of life is affected, hospital admittance rates are higher, the use of total parenteral nutrition is increased and interruption of treatment is more frequent, all of which compromise tumor control. Mucositis causes 9% to 19% of chemotherapy and radiotherapy interruption.

A common chemotherapeutic agent used in head and neck cancer is Cisplatin. Cisplatin (cis- diamminedichloroplatinum(II), CDDP) is an antineoplastic drug used in the treatment of many cancers including testicular cancer, ovarian cancer, bladder cancer, head and neck cancer, esophageal cancer, small and non-small cell lung cancer, breast cancer, cervical cancer, stomach cancer, prostate cancer, brain tumors, neuroblastoma, sarcomas, multiple myeloma, melanoma, mesothelioma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, pancreatic cancer, and thyroid cancer. While toxicities include ototoxicity, gastrotoxicity, myelosuppression, and allergic reactions, the main dose-limiting side effect of cisplatin is nephrotoxicity followed by ototoxicity.

Tempol is a piperidine nitroxide. Nitroxides are a class of stable free radical compounds that protects mammalian cells against numerous toxic agents. Tempol protects normal cells from radiation and cisplatin-induced damage; however, in cancerous or tumor cells, Tempol is reduced to its hydroxylamine form that does not and cannot protect the cells from radiation and cisplatin induced damage. This distinction is of particular importance in the setting of cancer treatment, in which both normal and tumor tissue is exposed to radiation and chemotherapy.

Without using Tempol, both normal cells and cancer cells suffer from toxicity. Tempol is the only known compound to possess this functional duality. This compound has the potential to prevent many of the toxicities associated with cisplatin and radiation treatment including the prevention of mucositis, nephrotoxicity, and ototoxicity.

Treatment of Radiation and Cisplatin Induced Toxicities With Tempol

A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy

To determine the efficacy of Tempol in reducing the incidence severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale.

The incidence will measure the number of patients who experience grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the number of patients who receive grade 3 or 4 mucositis over the course of the treatment is considered a positive change in incidence.

To determine the efficacy of Tempol in reducing the duration severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale.

This duration will be measured by total number of days number a patient experiences grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the total number of days a patient receives grade 3 or 4 mucositis over the course of the treatment is considered a positive change in duration.

Reduction in Serum Creatinine levels in active arm versus placebo arm.

Reduction in Blood Urea Nitrogen levels in active arm versus placebo arm.

To determine the efficacy of Tempol in reducing the time to onset of grades 1-4 mucositis on the World Health Organization (WHO) scale.

This time to onset will measure the number of days after exposure to cisplatin before a patient experiences grade 1 through 4 mucositis according to the World Health Organization (WHO) scale. An increase in the total number of days before a patient receives grade 1 through 4 mucositis after cisplatin exposure is considered a positive change in time to onset.

Matrix Biomed, Inc.

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Chronic Disease

Lymphoma

Anemia

Hematologic Diseases

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Micronutrients

Iron

Hepcidins

NOX-H94

Placebo solution

Kai Riecke, MD

This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in patients with anemia of chronic disease (ACD). Furthermore, this study is intended to provide data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to choose the appropriate dose and dose schedule of subsequent efficacy studies.

Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in iron concentrations in the blood and subsequently impair formation of red blood cells. Treatment with NOX-H94 is expected to inhibit this patho-mechanism by binding and inactivating hepcidin.

Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer

Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer

• Hb increase ≥1 g/dL OR reticulocyte index normalization (≥1%) at any time point until 1 week after the end of treatment

AND absence of all of the following treatment failure criteria until 1 week after the end of treatment:

* Erythrocyte transfusion, ESA or IV iron,
* Hb drop by ≥1 g/dL
* Treatment interruption due to adverse events (AEs)

Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint

Proportion of treatment failures at study visits V4, V6, V8, and V10, as defined for the primary efficacy endpoint

Adverse events, Safety signals derived from laboratory diagnostics, vital signs.

Absolute concentrations and change from baseline

TME Pharma AG

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Communicable Diseases

Papillomavirus Infections

Condylomata Acuminata

Warts

Epidermodysplasia Verruciformis

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

One product will be assigned to each hand to minimize treatment confusion for the participants.

PURELL VF481 Left Hand/ Placebo Right Hand

One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

PURELL VF481

One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Eliot Mostow, M.D>

The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.

* At least 5, but not more than 20 participants will be enrolled in the study.
* Each wart is randomly assigned a test product prior to the start of the study
* Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants
* The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.
* Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.
* Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.
* Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands

Data is not available due to study closure and data destruction

Cleveland Clinic Akron General

Purell VF481

15% alcohol formulation that aesthetically resembles VF481

Placebo

Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants

PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

PURELL VF481 Left Hand/ Placebo Right Hand

Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Solution Left Hand/ PURELL VF481 Right Hand

Total

Age, Categorical

Sex/Gender unspecified

Sex/Gender, Customized

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Eliot Mostow, MD

Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint

One product will be assigned to each hand to minimize treatment confusion for the participants.

PURELL VF481 Left Hand/ Placebo Right Hand

PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Solution: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

PURELL Left Hand/ Placebo Right Hand

One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

PURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Solution: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Solution Left Hand/ PURELL Right Hand

Change in Size of Warts Treated by Each Product at Each Time Point.

Warts are equally distributed between products so that an equal number of warts treated on each person One (1) product will be assigned to each hand to minimize treatment confusion for the participants

One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Placebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Radiation and Cisplatin Induced Toxicities With Tempol	NCT03480971	Mucositis Nephrotoxicity Ototoxicity	Tempol Placebo Solutio...	18 Years -	Matrix Biomed, Inc.
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer	NCT01691040	Anemia of Chron...	NOX-H94 Placebo solutio...	18 Years -	TME Pharma AG
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands	NCT00973856	Papillomavirus ... Warts Condylomata Acu... Epidermodysplas...	PURELL VF481 Placebo Solutio...	18 Years - 75 Years	Cleveland Clinic Akron General
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer	NCT01691040	Anemia of Chron...	NOX-H94 Placebo solutio...	18 Years -	TME Pharma AG

Spots Global Cancer Trial Database for placebo solution