Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Diclofenac Capsules to Treat Dental Pain

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

September 25, 2009
May 15, 2012
September 2009
December 2009   (final data collection date for primary outcome measure)
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.

Total Pain Relief (TOTPAR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00985439 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Study of Diclofenac Capsules to Treat Dental Pain
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

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

Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dental Pain
  • Drug: Diclofenac Test (lower dose)
    18-mg Single dose
  • Drug: Diclofenac Test (upper dose)
    35-mg Single dose
  • Drug: Celecoxib 400 mg
    Capsules 2 x 200 mg Single-dose
  • Drug: Placebo
    Capsules 2 Single-dose
  • Experimental: Diclofenac Test (lower dose)
    One 18-mg Diclofenac Test Capsule and 1 placebo capsule
    Intervention: Drug: Diclofenac Test (lower dose)
  • Experimental: Diclofenac Test (upper dose)
    One 35-mg Diclofenac Test Capsule and 1 placebo capsule
    Intervention: Drug: Diclofenac Test (upper dose)
  • Active Comparator: Celecoxib 400 mg
    Intervention: Drug: Celecoxib 400 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2009
December 2009   (final data collection date for primary outcome measure)

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
18 Years to 50 Years
Contact information is only displayed when the study is recruiting subjects
United States
Iroko Pharmaceuticals, LLC
Iroko Pharmaceuticals, LLC
Not Provided
Not Provided
Iroko Pharmaceuticals, LLC
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP