Wounds and Injuries

All Conditions

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Burns

Anemia, Sickle Cell

Anemia

Pain

Breakthrough Pain

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Anemia, Hemolytic

Anemia, Hemolytic, Congenital

Hematologic Diseases

Hemoglobinopathies

Genetic Diseases, Inborn

Neurologic Manifestations

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Adjuvants, Anesthesia

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Fentanyl

Analgesics, Opioid

Citric Acid

Sodium Citrate

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Anesthetics, Intravenous

Anesthetics, General

Citrate

ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])

John Messina

The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ (Oral Transmucosal Fentanyl Citrate \[OTFC\]) treatment in children with pain associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who are receiving around the clock (ATC) opioid therapy.

Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain

A 4-week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain

Cephalon

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Leiomyoma

Infertility

Myofibroma

Endometriosis

Endocrine System Diseases

Genital Diseases

Urogenital Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Hormones

Alan H DeCherney, M.D.

This study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education.

The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis or assist in the treatment of the patient. These additional tests will be conducted within the guidelines of current gynecologic practice. In some cases, the patient will receive medical or surgical treatment for their disorder.

The purpose of this study is to provide an opportunity for physicians to evaluate women with medical conditions of reproduction. These evaluations and treatments will support clinical training and research for the accredited training program in reproductive endocrinology at the National Institute of Child Health and Human Development (NICHD).\<TAB\>

The specific objective of this protocol is to gain knowledge and collect data in order to allow for hypothesis generation in future research as well as give NICHD investigators and trainees hands on experience related to the diagnoses, management, treatment and follow-up of reproductive endocrine disorders. Such disorders include but are not limited to Polycystic ovarian syndrome, Endometriosis, Primary ovarian insufficiency, Recurrent pregnancy loss, Primary amenorrhea and Infertility. This information will be taken from standard medical care/procedures and follow up of patients and healthy volunteers. It allows investigation into the problems of these patients for the purpose of furthering general knowledge and teaching.

Evaluation of Women With Endocrine and Reproductive-Related Conditions

Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions

To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ACTIQ®

John Messina, Pharm D

The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with cancer and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.

The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.

The secondary objectives are:

* to evaluate the characteristics of BTP in children with pain, including their response to treatment
* to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children with regard to time to adequate analgesia by utilizing a stop watch to measure the time for each unit of study drug in the double blind phase
* to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the occurrence of inadequate analgesia as assessed by the use of rescue medication
* to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the numbers of patients who withdraw from the study because of inadequate analgesia
* to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the duration of analgesic effect by using the FPS-R administered at approximately 30, 45, and 60 minutes after the start of each unit of study drug after an optimal dosage is obtained
* to determine the distribution of optimal doses of ACTIQ treatment for these children by age group (3 to under 6 years, 6 to under 11 years, and 11 to under 16 years)
* to establish a safe and effective titration scheme for ACTIQ in these children during the open label phase
* to evaluate the safety of ACTIQ treatment for these children through the assessment of adverse events, clinical laboratory assessments (serum chemistry and hematology), vital sign measurements (including blood pressure, heart rate, and respiration rate), hemoglobin-oxygen saturation level (SpO2, measured via pulse oximetry), electrocardiograms (ECGs), physical examinations, and level of sedation (measured by the University of Michigan Sedation Scale \[UMSS\])
* to characterize the pharmacokinetics profile of ACTIQ (fentanyl citrate) in these children
* to investigate the exposure and efficacy relationship between plasma concentration of fentanyl and clinical measures of analgesia

Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)

A Double-Blind, Placebo-Comparison Study to Evaluate the Efficacy and Safety of ACTIQ® (Oral Transmucosal Fentanyl Citrate [OTFC®]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain	NCT00236093	Pain Cancer Sickle Cell Ane... Severe Burns	ACTIQ (Oral Tra...	3 Years - 15 Years	Teva Branded Pharmaceutical Products R&D, Inc.
Evaluation of Women With Endocrine and Reproductive-Related Conditions	NCT00001850	Endocrine Disea... Infertility Leiomyoma Endometriosis Fibroids		1 Year - 85 Years	National Institutes of Health Clinical Center (CC)
Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)	NCT00236041	Cancer Breakthrough Pa...	ACTIQ®	3 Years - 15 Years	Teva Branded Pharmaceutical Products R&D, Inc.
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain	NCT00236093	Pain Cancer Sickle Cell Ane... Severe Burns	ACTIQ (Oral Tra...	3 Years - 15 Years	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for sickle cell

Every month we try and update this database with for sickle cell 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 sickle cell

Every month we try and update this database with for sickle cell 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 sickle cell 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.