Phase 3
Completed N=328
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Post Operative Dental Pain
Source: ClinicalTrials.gov NCT02476422 ↗
Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose — 47.3; 44.1 units on a scale — p=0.211
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose |
47.3; 44.1 | 0.211 |
| SECONDARY Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points |
9.2; 13.7; 24.1; 26.6; 38.9; 36.7 | — |
| SECONDARY Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points |
16.1914; 15.6262; 29.3759; 27.9216; 38.8570; 37.3448 | — |
| SECONDARY Time to Confirmed First Perceptible Pain Relief |
15.81665; 14.98335 | — |
| SECONDARY Time to Onset of Meaningful Pain Relief (MPR) |
41.67500; 42.02500 | — |
| SECONDARY Time to Onset of First Perceptible Pain Relief (FPR) |
15.81665; 14.85000 | — |
| SECONDARY Sum of Pain Intensity Difference (SPID) |
1.077; 1.049; 2.955; 2.772; 6.165; 6.196 | — |
| SECONDARY Summed Total Pain Relief (TOTPAR) at Different Time Points |
1.807; 1.780; 5.032; 4.817; 10.642; 10.848 | — |
| SECONDARY Peak Analgesic Effect |
1.9; 1.8; 3.6; 3.5; 61.3; 60.2 | — |
| SECONDARY Duration of Analgesia |
480.0; 480.0 | — |
| SECONDARY Number of Patients Needing Rescue Medication |
47; 36 | — |
| SECONDARY Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART) |
6; 10; 7; 7; 49; 34 | — |
| SECONDARY Number of Patients With Any Adverse Events, Serious Adverse Events and Death |
47; 47; 0; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level.
- Patients having a moderate to severe Baseline pain intensity as assessed by a score of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic dissipation.
Key Exclusion Criteria
- Patients who require the removal of a single third molar, or 2 ipsilateral third molars where mandibular molar is not fully or partially impacted.
- Patients with active peptic ulcer disease or a history of significant gastrointestinal disease or any gastrointestinal bleeding.
- Patients with coagulation or bleeding disorders.
- Patients with a positive drug or alcohol screen.
- Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic, muscle relaxant, or tranquilizer within 5 elimination half-lives before administration of study drug (other than surgical anesthetic prior to and during dental surgery).
Data sourced from ClinicalTrials.gov (NCT02476422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.