Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

NCT01626118 | Completed Phase 3 Results

• 1 other identifier: IND3-10-06
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Other Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.

  0-48 hours

Secondary Outcomes (7)

• 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.

  0-4 hours

• 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.

  0-8 hours

• 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.

  0-24 hours

• Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).

  0-4 hours

• TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours

  0-8 hours

Study Arms (4)

Indomethacin 40 mg TID

EXPERIMENTAL

Drug: Indomethacin

Indomethacin 40 mg BID

EXPERIMENTAL

Drug: Indomethacin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Indomethacin 20 mg TID

EXPERIMENTAL

Drug: Indomethacin

Interventions

Indomethacin DRUG

capsules, 40 mg, TID

Indomethacin 40 mg TID

Placebo DRUG

capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iroko Pharmaceuticals, LLC: lead

Study Sites (4)

Premier Research Group Limited

Phoenix, Arizona, 85027, United States

Location

Chesapeake Research Group, LLC

Pasadena, Maryland, 21122, United States

Location

Premier Research Group Limited

Austin, Texas, 78705, United States

Location

Premier Research Group Limited

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Daniel Solorio
• Organization: Iroko Pharmaceuticals, LLC

dsolorio@iroko.com

267-546-3150

Study Officials

• Jason Dickerson, DPM

  Premier Research Group Limited

  PRINCIPAL INVESTIGATOR

• Michael Golf, DPM

  Premier Research Group Limited

  PRINCIPAL INVESTIGATOR

• Ira Gottlieb, DPM

  Chesapeake Research Group, LLC

  PRINCIPAL INVESTIGATOR

• Kyle Patrick, DO

  Premier Research Group Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 17, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-02

Locations

US (4)