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NCT01470651 · ClinicalTrials.gov registry record · Phase 4
Armodafinil for Patients Starting Hepatitis C Virus Treatment
A Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
- Terminated
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01470651 is a Phase 4 study that was terminated before completion, run by Research Foundation for Mental Hygiene. The registered enrollment target is 26 participants.
The verdict
NCT01470651, a Phase 4 study, was terminated before completion, sponsored by Research Foundation for Mental Hygiene.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
Fatigue is one of the most common side effects of the treatment of hepatitis C infection with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation. Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and shift-work sleep disorder. This is a randomized placebo controlled study to determine whether patients assigned to armodafinil have fewer missed doses, dose reductions or treatment discontinuation due to side effects in the first 12 weeks of treatment for hepatitis C infection than do placebo patients. Placebo patients are offered 14 weeks of open label armodafinil after Week 12.
Interventions
- DRUG Armodafinil
- DRUG Sugar Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01470651
The ClinicalTrials.gov registry entry for NCT01470651 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Research Foundation for Mental Hygiene, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Armodafinil is the first listed.
NCT01470651 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01470651 about?
NCT01470651 is a clinical study titled "Armodafinil for Patients Starting Hepatitis C Virus Treatment". Fatigue is one of the most common side effects of the treatment of hepatitis C infection with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation. Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and shift-work sleep disorder. This...
What is the current status of trial NCT01470651?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2011-10. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01470651?
The interventions under investigation include: Armodafinil (DRUG), Sugar Pill (DRUG).
Who is sponsoring clinical trial NCT01470651?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
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