Clinical Trial: Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With
Brief 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.
Detailed Summary: Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. 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 anorexia and cachexia.
Sponsor: Helsinn Therapeutics (U.S.), Inc
Current Primary Outcome: Body weight; Lean body mass; Functional performance [ Time Frame: 4 weeks ]
Original Primary Outcome: Body weight; Lean body mass; Functional performance
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Helsinn Therapeutics (U.S.), Inc
Dates:
Date Received: September 18, 2006
Date Started: September 2006
Date Completion:
Last Updated: August 30, 2013
Last Verified: August 2013