Phase 3
N=462
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Other Acute Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01543685 ↗Enrolled (actual)
462
Serious AEs
0.2%
Results posted
Dec 2013
Primary outcome: Primary: The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) — 508.2; 329.8; 377.3; 280.5 mm*hour — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indomethacin (Drug); Celecoxib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Iroko Pharmaceuticals, LLC
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) |
508.2; 329.8; 377.3; 280.5; 69.4 | <0.001 sig |
| SECONDARY VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. |
30.7; 29.8; 17.9; 20.4; 8.9 | 0.013 sig |
| SECONDARY VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. |
64.1; 55.4; 45.7; 37.2; 12.0 | 0.001 sig |
| SECONDARY VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry |
226.9; 158.3; 176.9; 119.4; 28.3 | <0.001 sig |
| SECONDARY Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). |
2.5; 2.1; 1.7; 1.8; 1.2 | 0.003 sig |
| SECONDARY TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours |
4.5; 3.4; 3.4; 3.0; 1.5 | <0.001 sig |
| SECONDARY TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours |
13.4; 8.9; 10.0; 7.7; 2.6 | <0.001 sig |
| SECONDARY TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours |
29.3; 17.8; 19.6; 16.4; 5.2 | <0.001 sig |
Summary
The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
Eligibility Criteria
Inclusion Criteria
- Patient is male or female between 18 and 65 years of age
- For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
- Patient must be willing to stay at the study site ≥ 72 hours
Exclusion Criteria
- Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
- Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- Patient has used or intends to use any of the medications that are prohibited by the protocol
- Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
- Patient has taken another investigational drug within 30 days prior to screening
Data sourced from ClinicalTrials.gov (NCT01543685). 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.