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NCT01387269 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
A Phase 3 study, sponsored by Helsinn Therapeutics (U.S.).
- Completed
- Registry status
- Phase 3
- Development phase
- 484
- Enrollment target
NCT01387269 is a Phase 3 study that has completed, run by Helsinn Therapeutics (U.S.). The registered enrollment target is 484 participants.
The verdict
NCT01387269, a Phase 3 study, has completed, sponsored by Helsinn Therapeutics (U.S.).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 484 participants
- Enrollment target
Study Summary
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Interventions
- DRUG Placebo
- DRUG Anamorelin HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01387269
The ClinicalTrials.gov registry entry for NCT01387269 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Therapeutics (U.S.), which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01387269 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01387269 about?
NCT01387269 is a clinical study titled "Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)". The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
What is the current status of trial NCT01387269?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 484 participants. The study started on 2011-07. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01387269?
The interventions under investigation include: Placebo (DRUG), Anamorelin HCl (DRUG).
Who is sponsoring clinical trial NCT01387269?
This trial is sponsored by Helsinn Therapeutics (U.S.), which has 10 total clinical trials registered on ClinicalTrials.gov.
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