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NCT03375203 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 365
- Enrollment target
NCT03375203: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03375203 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 365 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (174% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03375203, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 365 participants
- Enrollment target
Study Summary
The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.
Primary Outcome
Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.
Interventions
- DRUG Placebo
- DRUG Zolpidem
- DRUG JNJ-42847922, 5 mg
- DRUG JNJ-42847922, 10 mg
- DRUG JNJ-42847922, 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2017-11-23 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 2 |
What the finished NCT03375203 record still lists
NCT03375203 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (174% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03375203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03375203 about?
NCT03375203 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder". The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 day...
What is the current status of trial NCT03375203?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 365 participants. The study started on 2017-11-23. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT03375203?
The interventions under investigation include: Placebo (DRUG), Zolpidem (DRUG), JNJ-42847922, 5 mg (DRUG), JNJ-42847922, 10 mg (DRUG), JNJ-42847922, 20 mg (DRUG).
Who is sponsoring clinical trial NCT03375203?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03375203's enrollment target sits among peer trials
365 121st of 2000 higher than 1,880 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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