Phase 3 N=428 Randomized Triple-blind Treatment

Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Bottom Line

View on ClinicalTrials.gov: NCT01462435 ↗

Enrolled (actual)

428

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), ANCOVA Model. — 390.468; 392.954; 524.315; 76.887 mm*hour — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Diclofenac Test (lower dose) (Drug); Diclofenac Test (upper dose) (Drug); Celecoxib (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Iroko Pharmaceuticals, LLC
Primary completion: Feb 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), ANCOVA Model.	390.468; 392.954; 524.315; 76.887	<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.	25.109; 27.450; 31.568; 14.406	0.043 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.	51.675; 56.404; 64.689; 23.151	0.009 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.	170.845; 177.101; 230.708; 48.811	<0.001 sig
SECONDARY Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.	2.226; 2.112; 2.530; 1.387	0.009 sig
SECONDARY TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours	3.840; 3.690; 4.652; 1.943	0.002 sig
SECONDARY TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours	10.670; 10.186; 13.325; 3.566	<0.001 sig
SECONDARY TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours	22.972; 21.635; 28.054; 4.925	<0.001 sig

Summary

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01462435). 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.