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NCT01365052 · ClinicalTrials.gov registry record · Phase 3
Safety Trial of Naproxen Sodium/ Diphenhydramine
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT01365052: Completed Phase 3 study, sponsored by Bayer.
NCT01365052 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01365052, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
Primary Outcome
Please see further details in Adverse Events (AE) section
Interventions
- DRUG Placebo
- DRUG Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT01365052 record still lists
NCT01365052 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01365052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01365052 about?
NCT01365052 is a clinical study titled "Safety Trial of Naproxen Sodium/ Diphenhydramine". The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
What is the current status of trial NCT01365052?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2011-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01365052?
The interventions under investigation include: Placebo (DRUG), Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) (DRUG).
Who is sponsoring clinical trial NCT01365052?
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 NCT01365052's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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