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Completed

NCT Number: NCT00964431

Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

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

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Key information

Conditions

Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Premier Research Group Limited

Austin, Texas, 78705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib 400 mg

Drug

Capsules 2 x 200 mg Single-Dose

Placebo

Drug

Capsules 2 Single-Dose

Indomethacin Test (lower dose)

Drug

20-mg single dose

Indomethacin Test (upper dose)

Drug

40-mg single dose

Primary outcomes

  1. Total Patient Pain Relief Over 0 to 8 Hours.

    Time frame: 8 hours

    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.

Sponsors and collaborators

Lead sponsor

Iroko Pharmaceuticals, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2009
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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