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A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder

NCT03375203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2025-04-29

Study results available
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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.

Conditions

  • Insomnia Disorders

Interventions

DRUG

Placebo

Matching placebo will be administered once daily based upon dosing group.

DRUG

JNJ-42847922, 5 mg

JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily.

DRUG

JNJ-42847922, 10 mg

JNJ-42847922 will be administered as 10 mg oral capsule once daily.

DRUG

JNJ-42847922, 20 mg

JNJ-42847922 will be administered as 20 mg oral capsule once daily.

DRUG

Zolpidem

Zolpidem will be administered as 5 mg or 10 mg (2\*5mg capsule) oral capsule once daily based upon the local labeling information.

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
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-23
Primary Completion
2019-04-03
Completion
2019-04-03
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Japan
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375203 on ClinicalTrials.gov