A Phase 3 interventional study of Gabapentin and Placebo in Transient Insomnia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 256 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Gabapentin
Drug: Placebo
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
Matched placebo 30 minutes prior to bedtime for 28 days
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Time frame: Day 1
PSG WAPSO
Time frame: Day 28
PSG Latency to Persistent Sleep (LPS)
Time frame: Days 1 and 28
PSG Sleep Onset Latency (SOL)
Time frame: Days 1 and 28
PSG Number of Awakenings (NAW)
Time frame: Days 1 and 28
PSG Wake after Sleep Onset (WASO)
Time frame: Days 1 and 28
PSG Total Wake Time (TWT) plus Stage 1 Sleep
Time frame: Days 1 and 28
PSG Wake Time During Sleep (WTDS)
Time frame: Days 1 and 28
PSG Total Sleep Time (TST)
Time frame: Days 1 and 28
PSG Sleep Efficiency (SE)
Time frame: Days 1 and 28
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time frame: Days 1 and 28
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
Time frame: Days 1 and 28
Subjective SL
Time frame: Days 1 and 28
Subjective NA
Time frame: Days 1 and 28
Subjective WASO
Time frame: Days 1 and 28
Subjective TST
Time frame: Days 1 and 28
Subjective ASR
Time frame: Days 1 and 28
Subjective ASQ
Time frame: Days 1 and 28
Karolinska Sleep Diary (KSD)-Sleep Quality Index
Time frame: Days 1 and 28
KSD individual scores
Time frame: Days 1 and 28
Vital signs
Time frame: Days 1 and 28
Adverse events
Time frame: Through Day 32
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.