Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
This study has been completed.
Sponsor:
Iroko Pharmaceuticals, LLC
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01626118
First received: June 20, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Other Acute Postoperative Pain |
Drug: Indomethacin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy |
Resource links provided by NLM:
Further study details as provided by Iroko Pharmaceuticals, LLC:
Primary Outcome Measures:
- VAS summed pain intensity difference (VAS SPID) over 0 to 48 hours (VAS SPID-48) after Time 0 [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- VAS pain intensity difference (VAS PID) at each scheduled time point up to 48 hours [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
- VAS pain intensity score at each scheduled time point [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
| Enrollment: | 373 |
| Study Start Date: | June 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Indomethacin higher dose TID |
Drug: Indomethacin
capsules, higher dose, TID
|
| Experimental: Indomethacin higher dose BID |
Drug: Indomethacin
capsules, higher dose, BID
|
| Placebo Comparator: Placebo |
Drug: Placebo
capsules
|
| Experimental: Indomethacin lower dose TID |
Drug: Indomethacin
capsules, lower dose, TID
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626118
Locations
| United States, Arizona | |
| Premier Research Group Limited | |
| Phoenix, Arizona, United States, 85027 | |
| United States, Maryland | |
| Chesapeake Research Group, LLC | |
| Pasadena, Maryland, United States, 21122 | |
| United States, Texas | |
| Premier Research Group Limited | |
| Austin, Texas, United States, 78705 | |
| United States, Utah | |
| Premier Research Group Limited | |
| Salt Lake City, Utah, United States, 84107 | |
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Iroko Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01626118 History of Changes |
| Other Study ID Numbers: | IND3-10-06 |
| Study First Received: | June 20, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents |
Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013