Study of Diclofenac Capsules to Treat Dental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00985439
First received: September 25, 2009
Last updated: May 15, 2012
Last verified: March 2012
  Purpose

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


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

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 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Resource links provided by NLM:


Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Total Patient Pain Relief Over 0 to 12 Hours. [ Time Frame: 12 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 0-12 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 60.



Enrollment: 202
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Test (lower dose)
One 18-mg Diclofenac Test Capsule and 1 placebo capsule
Drug: Diclofenac Test (lower dose)
18-mg Single dose
Experimental: Diclofenac Test (upper dose)
One 35-mg Diclofenac Test Capsule and 1 placebo capsule
Drug: Diclofenac Test (upper dose)
35-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 overnight

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985439

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: NCT00985439     History of Changes
Other Study ID Numbers: DIC2-08-03
Study First Received: September 25, 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
Facial Pain
Pain
Signs and Symptoms
Stomatognathic Diseases
Tooth Diseases
Celecoxib
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014