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NCT01929031 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 562
- Enrollment target
NCT01929031: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01929031 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 562 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01929031, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 562 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).
Primary Outcome
SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
Interventions
- DRUG ibuprofen
- DRUG ibuprofen + caffeine
- DRUG caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01929031 record still lists
NCT01929031 is an interventional study that assigns participants to a tested intervention. The registered 562 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 (27% lower).
The record links to 0 conditions, and to 3 interventions - of which ibuprofen is the first listed.
NCT01929031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01929031 about?
NCT01929031 is a clinical study titled "Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain". The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medica...
What is the current status of trial NCT01929031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 562 participants. The study started on 2013-08. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01929031?
The interventions under investigation include: ibuprofen (DRUG), ibuprofen + caffeine (DRUG), caffeine (DRUG).
Who is sponsoring clinical trial NCT01929031?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01929031's enrollment target sits among peer trials
562 669th of 2000 higher than 1,331 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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