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NCT00378131 · ClinicalTrials.gov registry record · Phase 2
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
A Phase 2 study of Cancer Cachexia, sponsored by Helsinn Therapeutics (U.S.).
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 17
- Study locations
NCT00378131: Completed Phase 2 study of Cancer Cachexia, sponsored by Helsinn Therapeutics (U.S.).
NCT00378131 is a Phase 2 study of Cancer Cachexia that has completed, run by Helsinn Therapeutics (U.S.). The registered enrollment target is 51 participants, below the 133-participant average among 6 other Cancer Cachexia trials with a reported enrollment target (62% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00378131, a Phase 2 study of Cancer Cachexia, has completed, sponsored by Helsinn Therapeutics (U.S.).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 17
- Study locations
Study Summary
Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.
Conditions Studied
Interventions
- DRUG placebo
- DRUG RC-1291
Study Locations (17)
South Carolina
- Charleston Cancer Center - Charleston
- South Carolina Oncology Associates, PA - Columbia
- South Carolina Cancer Specialists - Hilton Head Island
California
- San Diego Pacific Oncology & Hematology Associates - Encinitas
- Sant P. Chawla, MD - Santa Monica
Maryland
- Center for Cancer and Blood Disorders - Bethesda
- Chesapeake Oncology Hematology Associates, PA - Glen Burnie
Texas
- University of Texas Medical Branch - Galveston
- Michael E. DeBakey VA Medical Center - Houston
Virginia
- Cancer Outreach Associates - Abingdon
- Virginia Cancer Institute - Richmond
Washington
- Multicare Health System - Tacoma
- Northwest Medical Specialties - Tacoma
Arizona
- Palo Verde Hematology Oncology, Ltd. - Glendale
Florida
- Melbourne Internal Medicine Associates - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
What the finished NCT00378131 record still lists
NCT00378131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 6 other Cancer Cachexia trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Cancer Cachexia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00378131 lists 17 locations in 10 states (South Carolina, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT00378131 about?
NCT00378131 is a clinical study titled "Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia". Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety ...
What is the current status of trial NCT00378131?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2006-09. Estimated completion is 2007-04.
What conditions does trial NCT00378131 study?
This clinical trial studies the following conditions: Cancer Cachexia.
What interventions are being tested in trial NCT00378131?
The interventions under investigation include: placebo (DRUG), RC-1291 (DRUG).
Who is sponsoring clinical trial NCT00378131?
This trial is sponsored by Helsinn Therapeutics (U.S.), which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00378131 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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