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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00219817
Other study ID # RC-1291-203
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated August 30, 2013
Start date June 2005
Est. completion date October 2006

Study information

Verified date August 2013
Source Helsinn Therapeutics (U.S.), Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Anorexia and weight loss 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 weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
RC-1291 HCl


Locations

Country Name City State
United States Cancer Outreach Associates Abingdon Virginia
United States Massachusetts General Hospital Boston Massachusetts
United States Fletcher Allen Health Care Burlington Vermont
United States University of Texas Medical Branch at Galveston Galveston Texas
United States California Cancer Care Center Greenbrae California
United States Michael E. DeBakey Veterans Affairs Medical Center Houston Texas
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Helsinn Therapeutics (U.S.), Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight
Primary Lean Body Mass
Primary Functional Performance
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