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NCT00378131 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Cancer Cachexia, sponsored by Helsinn Therapeutics (U.S.).

Completed
Registry status
Phase 2
Development phase
51
Enrollment target
17
Study locations

NCT00378131 is a Phase 2 study of Cancer Cachexia that has completed, run by Helsinn Therapeutics (U.S.). The registered enrollment target is 51 participants, below the 133-participant average among 6 other Cancer Cachexia trials with a reported enrollment target (62% lower). The trial reports 17 study locations across 10 states.

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The verdict

NCT00378131, a Phase 2 study of Cancer Cachexia, has completed, sponsored by Helsinn Therapeutics (U.S.).

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target
17
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG RC-1291

Study Locations (17)

South Carolina

  • Charleston Cancer Center - Charleston
  • South Carolina Oncology Associates, PA - Columbia
  • South Carolina Cancer Specialists - Hilton Head Island

California

  • San Diego Pacific Oncology & Hematology Associates - Encinitas
  • Sant P. Chawla, MD - Santa Monica

Maryland

  • Center for Cancer and Blood Disorders - Bethesda
  • Chesapeake Oncology Hematology Associates, PA - Glen Burnie

Texas

  • University of Texas Medical Branch - Galveston
  • Michael E. DeBakey VA Medical Center - Houston

Virginia

  • Cancer Outreach Associates - Abingdon
  • Virginia Cancer Institute - Richmond

Washington

  • Multicare Health System - Tacoma
  • Northwest Medical Specialties - Tacoma

Arizona

  • Palo Verde Hematology Oncology, Ltd. - Glendale

Florida

  • Melbourne Internal Medicine Associates - Melbourne

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2006-09
Est. Completion 2007-04
Phase Phase 2

Sponsor

Helsinn Therapeutics (U.S.)

10 total trials

What the Registry Record Tells You About NCT00378131

The ClinicalTrials.gov registry entry for NCT00378131 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 6 other Cancer Cachexia trials with a reported enrollment target (62% lower). The listed sponsor is Helsinn Therapeutics (U.S.), which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer Cachexia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00378131 reports 17 study locations spanning 10 distinct geographic areas - top geographies include South Carolina, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT00378131 about?

NCT00378131 is a clinical study titled "Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia". 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 ...

What is the current status of trial NCT00378131?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2006-09. Estimated completion is 2007-04.

What conditions does trial NCT00378131 study?

This clinical trial studies the following conditions: Cancer Cachexia.

What interventions are being tested in trial NCT00378131?

The interventions under investigation include: placebo (DRUG), RC-1291 (DRUG).

Who is sponsoring clinical trial NCT00378131?

This trial is sponsored by Helsinn Therapeutics (U.S.), which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00378131 being conducted?

This trial has 17 study locations across Arizona, California, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.