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Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

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ClinicalTrials.gov Identifier: NCT00964431
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : March 30, 2012
Last Update Posted : May 22, 2012
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dental Pain
Interventions Drug: Celecoxib 400 mg
Drug: Placebo
Drug: Indomethacin Test (lower dose)
Drug: Indomethacin Test (upper dose)
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo
Hide Arm/Group Description [Not Specified] Single dose [Not Specified] [Not Specified]
Period Title: Overall Study
Started 50 51 51 51
Completed 50 51 51 51
Not Completed 0 0 0 0
Arm/Group Title Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo Total
Hide Arm/Group Description [Not Specified] Single dose [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 50 51 51 51 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 51 participants 51 participants 203 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
51
 100.0%
51
 100.0%
51
 100.0%
203
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 51 participants 51 participants 203 participants
22.0  (3.32) 22.2  (3.81) 22.1  (3.46) 22.1  (2.97) 22.1  (3.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 51 participants 51 participants 203 participants
Female
32
  64.0%
31
  60.8%
34
  66.7%
35
  68.6%
132
  65.0%
Male
18
  36.0%
20
  39.2%
17
  33.3%
16
  31.4%
71
  35.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 51 participants 51 participants 51 participants 203 participants
50 51 51 51 203
1.Primary Outcome
Title Total Patient Pain Relief Over 0 to 8 Hours.
Hide Description

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.

Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo
Hide Arm/Group Description:
20-mg
40-mg
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 51 51 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
10.794
(8.131 to 13.456)
12.564
(9.928 to 15.200)
14.822
(12.185 to 17.460)
3.019
(0.381 to 5.656)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin Test (Upper Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.545
Confidence Interval (2-Sided) 95%
5.816 to 13.275
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.8912
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo
Hide Arm/Group Description [Not Specified] Single dose [Not Specified] [Not Specified]
All-Cause Mortality
Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/51 (0.00%)   0/51 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Indomethacin Test (Lower Dose) Indomethacin Test (Upper Dose) Celecoxib 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/50 (38.00%)   26/51 (50.98%)   19/51 (37.25%)   29/51 (56.86%) 
Gastrointestinal disorders         
Alveolar osteitis  1  2/50 (4.00%)  5/51 (9.80%)  5/51 (9.80%)  4/51 (7.84%) 
Vomiting  1  2/50 (4.00%)  5/51 (9.80%)  2/51 (3.92%)  2/51 (3.92%) 
Injury, poisoning and procedural complications         
Post procedural swelling  1  3/50 (6.00%)  5/51 (9.80%)  3/51 (5.88%)  4/51 (7.84%) 
Nervous system disorders         
Dizziness  1  0/50 (0.00%)  2/51 (3.92%)  0/51 (0.00%)  4/51 (7.84%) 
Headache  1  3/50 (6.00%)  4/51 (7.84%)  4/51 (7.84%)  8/51 (15.69%) 
Nausea  1  8/50 (16.00%)  6/51 (11.76%)  5/51 (9.80%)  12/51 (23.53%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  1/50 (2.00%)  4/51 (7.84%)  3/51 (5.88%)  1/51 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1 or higher
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steven Jensen
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3003
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00964431     History of Changes
Other Study ID Numbers: IND2-08-03
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: November 22, 2011
Results First Posted: March 30, 2012
Last Update Posted: May 22, 2012