Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 326 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365052
The ClinicalTrials.gov registry entry for NCT01365052 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01365052 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.