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:
NCT00267358
First received: December 19, 2005
Last updated: August 30, 2013
Last verified: August 2013

December 19, 2005
August 30, 2013
November 2005
October 2006   (final data collection date for primary outcome measure)
  • Body weight
  • Lean body mass
  • Functional performance
Same as current
Complete list of historical versions of study NCT00267358 on ClinicalTrials.gov Archive Site
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Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
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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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Cancer Cachexia
  • Drug: RC-1291 HCl
  • Drug: Placebo
  • Active Comparator: RC-1291 HCl
    50 mg
    Intervention: Drug: RC-1291 HCl
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer.
  • Involuntary loss of body weight of ≥ 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
 
NCT00267358
RC-1291-205
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Helsinn Therapeutics (U.S.), Inc
Not Provided
Study Director: William Polvino, MD Helsinn Therapeutics (U.S.), Inc
Helsinn Therapeutics (U.S.), Inc
August 2013

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