Phase 3 Completed N=373 Randomized Triple-blind Treatment

Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

Summary

The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.

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

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

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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. Informational only — not medical advice.