9 results
Primary ObjectiveTo evaluate the effect of JNJ-42847922 on sleep latency (latency to persistent sleep [LPS]) in MDD subjects, stably treated with an SSRI/SNRI, who suffer from insomnia.Secondary Objectives* To investigate the safety, tolerability,…
Primary Objective:To investigate the safety and tolerability of JNJ-42847922 in subjects with MDD. Study medication will be administered for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other subjects.Secondary Objectives…
The purpose of this study is to see if JNJ-42847922 is useful for treating patients with insomnia without any other psychiatric disease. The safety of JNJ-42847922 will also be studied.
To evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at…
The objectives of this open-label extension*safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety…
Induction Phase (IP)* To independently evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing clinical remission and endoscopic improvement at the end of the Induction Phase (Week 14)Maintenance Phase (MP)* To…
The primary efficacy objectives for this study are as follows:* To evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the MCS at W14* To evaluate the efficacy of…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
The objectives of this open-label extension safety monitoring (OLE-SM) study are as follows:Part 1 (Open-Label Extension; OLE)• To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE)Part 2 (Safety Monitoring…