Phase 3
N=373
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Other Acute Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01626118 ↗Enrolled (actual)
373
Serious AEs
0.0%
Results posted
Mar 2014
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) — 598.670; 623.162; 342.779; 280.517 mm*hour — p=0.034
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indomethacin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Iroko Pharmaceuticals, LLC
- Primary completion
- Aug 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) |
598.670; 623.162; 342.779; 280.517 | 0.034 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. |
31.5; 35.3; 24.8; 18.4 | 0.191 |
| 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. |
69.7; 75.5; 47.6; 35.8 | 0.079 |
| 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. |
268.4; 265.2; 156.8; 115.5 | 0.020 sig |
| SECONDARY Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). |
2.6; 2.8; 2.0; 1.9 | 0.141 |
| SECONDARY TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours |
5.0; 5.4; 3.5; 3.0 | 0.049 sig |
| SECONDARY TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours |
16.2; 16.8; 10.1; 7.8 | 0.021 sig |
| SECONDARY TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours |
34.7; 37.0; 21.2; 17.3 | 0.036 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 (NCT01626118). 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.