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NCT01277107 · ClinicalTrials.gov registry record · Phase 2
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia
A Phase 2 study of Insomnia, sponsored by Intec Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 6
- Study locations
NCT01277107: Completed Phase 2 study of Insomnia, sponsored by Intec Pharma.
NCT01277107 is a Phase 2 study of Insomnia that has completed, run by Intec Pharma. The registered enrollment target is 83 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (51% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277107, a Phase 2 study of Insomnia, has completed, sponsored by Intec Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.
Primary Outcome
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Conditions Studied
Interventions
- DRUG Placebo capsule
- DRUG Zaleplon AP formulation
Study Locations (6)
Florida
- Miami Research Associates - Miami
- Broward Research Group - Pembroke Pines
- CRG of St. Petersburg - St. Petersburg
California
- Pacific Sleep Medicine - San Diego
Kansas
- Vince and Associates Clinical Research - Overland Park
Other
- Rambam sleep center - Haifa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
What the finished NCT01277107 record still lists
NCT01277107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo capsule is the first listed.
NCT01277107 lists 6 locations in 4 states (Florida, California, Kansas).
Frequently Asked Questions
What is clinical trial NCT01277107 about?
NCT01277107 is a clinical study titled "A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia". This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.
What is the current status of trial NCT01277107?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2011-01. Estimated completion is 2011-09.
What conditions does trial NCT01277107 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT01277107?
The interventions under investigation include: Placebo capsule (DRUG), Zaleplon AP formulation (DRUG).
Who is sponsoring clinical trial NCT01277107?
This trial is sponsored by Intec Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01277107 being conducted?
This trial has 6 study locations across California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01277107's enrollment target sits among peer trials
83 72nd of 151 higher than 79 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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