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Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00964431
First received: August 24, 2009
Last updated: May 15, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.


Condition Intervention Phase
Dental Pain
 Drug: Celecoxib 400 mg
Drug: Placebo
Drug: Indomethacin Test (lower dose)
Drug: Indomethacin Test (upper dose)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin Test Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Total Patient Pain Relief Over 0 to 8 Hours. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

    Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours.

    Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max

    The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32.



Enrollment: 203
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin Test (lower dose) Drug: Indomethacin Test (lower dose)
20-mg single dose
Experimental: Indomethacin Test (upper dose)
Single dose
 Drug: Indomethacin Test (upper dose)
40-mg single dose
Active Comparator: Celecoxib 400 mg Drug: Celecoxib 400 mg
Capsules 2 x 200 mg Single-Dose
Placebo Comparator: Placebo Drug: Placebo
Capsules 2 Single-Dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female between 18 and 50 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
  • Patient requires extraction of 2 or more third molars
  • Patient must be willing to stay at the study site for at least 8 hours after dosing of the study drug

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: NCT00964431

Locations
United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00964431     History of Changes
Other Study ID Numbers: IND2-08-03
Study First Received: August 24, 2009
Results First Received: November 22, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Indomethacin
Celecoxib
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
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013