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Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia

This study has been completed.
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT00378131
First received: September 18, 2006
Last updated: June 30, 2009
Last verified: June 2009
History of Changes

September 18, 2006
June 30, 2009
September 2006
April 2007   (final data collection date for primary outcome measure)
Body weight; Lean body mass; Functional performance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Body weight; Lean body mass; Functional performance
Complete list of historical versions of study NCT00378131 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
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 Cancer Anorexia/Cachexia

Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virture 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.

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 virture 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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cancer Cachexia
  • Drug: RC-1291
    50 mg
    Other Name: RC-1291
  • Drug: placebo
    placebo
    Other Name: placebo
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    RC-1291
    Intervention: Drug: RC-1291
  • Experimental: 3
    RC-1291
    Intervention: Drug: RC-1291
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.
  • Involuntary loss of body weight greater than 5% within the past 6 months

Exclusion Criteria:

  • Presently hospitalized or in a nursing care facility.
  • Inability to increase food intake from secondary causes.
  • Liver disease
  • If female-pregnant, breast-feeding or of childbearing potential.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00378131
RC-1291-206
Yes
Not Provided
Helsinn Therapeutics (U.S.), Inc
Not Provided
Study Director: William Polvino, MD Helsinn Therapeutics (U.S.), Inc
Helsinn Therapeutics (U.S.), Inc
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP