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NCT01229449 · ClinicalTrials.gov registry record · Phase 3
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
A Phase 3 study, sponsored by Reckitt Benckiser.
- Completed
- Registry status
- Phase 3
- Development phase
- 678
- Enrollment target
NCT01229449: Completed Phase 3 study, sponsored by Reckitt Benckiser.
NCT01229449 is a Phase 3 study that has completed, run by Reckitt Benckiser. The registered enrollment target is 678 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01229449, a Phase 3 study, has completed, sponsored by Reckitt Benckiser.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 678 participants
- Enrollment target
Study Summary
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
Primary Outcome
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pai
Interventions
- DRUG Placebo
- DRUG Ibuprofen/acetaminophen
- DRUG Ibuprofen/acetaminophen (higher dose)
- DRUG Nurofen Plus®
- DRUG Panadeine® Extra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 678 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT01229449 record still lists
NCT01229449 is an interventional study that assigns participants to a tested intervention. The registered 678 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 (12% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01229449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01229449 about?
NCT01229449 is a clinical study titled "Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study". The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
What is the current status of trial NCT01229449?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 678 participants. The study started on 2009-01. Estimated completion is 2009-09.
What interventions are being tested in trial NCT01229449?
The interventions under investigation include: Placebo (DRUG), Ibuprofen/acetaminophen (DRUG), Ibuprofen/acetaminophen (higher dose) (DRUG), Nurofen Plus® (DRUG), Panadeine® Extra (DRUG).
Who is sponsoring clinical trial NCT01229449?
This trial is sponsored by Reckitt Benckiser, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01229449's enrollment target sits among peer trials
678 536th of 2000 higher than 1,464 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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