Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01280591 · ClinicalTrials.gov registry record · Phase 3
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 712
- Enrollment target
NCT01280591: Completed Phase 3 study, sponsored by Bayer.
NCT01280591 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 712 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280591, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 712 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
Primary Outcome
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. 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.
Interventions
- DRUG Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
- DRUG Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)
- DRUG Naproxen sodium 440 mg (BAYH6689)
- DRUG DPH 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
What the finished NCT01280591 record still lists
NCT01280591 is an interventional study that assigns participants to a tested intervention. The registered 712 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) is the first listed.
NCT01280591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01280591 about?
NCT01280591 is a clinical study titled "Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain". The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone i...
What is the current status of trial NCT01280591?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 712 participants. The study started on 2010-10. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01280591?
The interventions under investigation include: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) (DRUG), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) (DRUG), Naproxen sodium 440 mg (BAYH6689) (DRUG), DPH 50 mg (DRUG).
Who is sponsoring clinical trial NCT01280591?
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 NCT01280591's enrollment target sits among peer trials
712 499th of 2000 higher than 1,500 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05208762 · 714 participants · Phase 1
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- NCT06758401 · 714 participants · Phase 3
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
- NCT06179160 · 710 participants · Phase 1
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- NCT06235697 · 710 participants · Phase 3
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia