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NCT01118273 · ClinicalTrials.gov registry record · Phase 4
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 162
- Enrollment target
NCT01118273: Completed Phase 4 study, sponsored by Bayer.
NCT01118273 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 162 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118273, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 162 participants
- Enrollment target
Study Summary
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
Primary Outcome
Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as "awake" from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.
Interventions
- DRUG Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
- DRUG Naproxen Sodium 440 mg (BAYH6689)
- DRUG Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
- DRUG Naproxen Sodium 220 mg (BAYH6689)
- DRUG DPH 50mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT01118273 record still lists
NCT01118273 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 5 interventions - of which Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg is the first listed.
NCT01118273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01118273 about?
NCT01118273 is a clinical study titled "Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine". The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
What is the current status of trial NCT01118273?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 162 participants. The study started on 2008-01. Estimated completion is 2008-02.
What interventions are being tested in trial NCT01118273?
The interventions under investigation include: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg (DRUG), Naproxen Sodium 440 mg (BAYH6689) (DRUG), Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg (DRUG), Naproxen Sodium 220 mg (BAYH6689) (DRUG), DPH 50mg (DRUG).
Who is sponsoring clinical trial NCT01118273?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01118273's enrollment target sits among peer trials
162 503rd of 2000 higher than 1,495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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