Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity
NCT02464046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-04-27
Summary
The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple dose administration to participants with insomnia disorder without psychiatric comorbidity.
Conditions
Interventions
- DRUG
-
JNJ-42847922
Participants in arm JNJ-42847922 then Placebo will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 1 and participants in arm Placebo then JNJ-42847922 will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 2.
- DRUG
-
Participants in arm JNJ-42847922 then Placebo will receive matching Placebo orally once daily from Day 1 to Day 5 in Period 2 and participants in arm Placebo then JNJ-42847922 will receive matching placebo orally once daily from Day 1 to Day 5 in Period 1.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-27
- Primary Completion
- 2015-12-02
- Completion
- 2015-12-02
- FDA Drug
- Yes
Countries
- United States
- Germany
- Netherlands
Study Locations
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