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