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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01277107
The ClinicalTrials.gov registry entry for NCT01277107 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (51% lower). The listed sponsor is Intec Pharma, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.