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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00267358
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : September 2, 2013
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Drug: RC-1291 HCl Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : November 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: RC-1291 HCl
50 mg
 Drug: RC-1291 HCl
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Body weight
  2. Lean body mass
  3. Functional performance

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267358


Locations
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Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Investigators
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Study Director: William Polvino, MD Helsinn Therapeutics (U.S.), Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00267358    
Other Study ID Numbers: RC-1291-205
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Weight Loss
Body Weight Changes
 Body Weight
Thinness
Metabolic Diseases
Nutrition Disorders