CompletedNCT00964431Updated May 22, 2012Results posted

Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

A Phase 2 interventional study of Celecoxib 400 mg and Placebo in Dental Pain, sponsored by Iroko Pharmaceuticals, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-05-22.

Sponsored by Iroko Pharmaceuticals, LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 203
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Dental Pain

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Toothache 140

In context

Toothache

140 studies on the registry are indexed under Toothache; 24 are open to participants now.

This study's enrollment of 203 is above the median of 100 across 121 interventional studies indexed under Toothache.

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Lead sponsor

Iroko Pharmaceuticals, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 203 participants (actual)

Study arms

Experimental
Indomethacin Test (lower dose)
Drug: Indomethacin Test (lower dose)
Experimental
Indomethacin Test (upper dose)
Single dose
Drug: Indomethacin Test (upper dose)
Active comparator
Celecoxib 400 mg
Drug: Celecoxib 400 mg
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugCelecoxib 400 mg
Capsules 2 x 200 mg Single-Dose
DrugPlacebo
Capsules 2 Single-Dose
DrugIndomethacin Test (lower dose)
20-mg single dose
DrugIndomethacin Test (upper dose)
40-mg single dose

What researchers measure

Primary outcomes

Total Patient Pain Relief Over 0 to 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.
Time frame: 8 hours

Results

Posted Mar 30, 2012

Participant flow

Participant flow — Overall Study
Milestone	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo
Started	50	51	51	51
Completed	50	51	51	51
Not completed	0	0	0	0

Outcome measures

PrimaryTotal Patient Pain Relief Over 0 to 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.

Time frame:: 8 hours
Reported as:: Least squares mean · units on a scale

Total Patient Pain Relief Over 0 to 8 Hours.
units on a scale	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo
Total Patient Pain Relief Over 0 to 8 Hours.	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)

Statistical analysis

Indomethacin Test (Upper Dose) vs Placebo · ANCOVA · p = <0.001 · Mean difference (net): 9.545 · 95% CI 5.816 to 13.275

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Indomethacin Test (Lower Dose)	—	0/50 (0%)	19/50 (38%)
Indomethacin Test (Upper Dose)	—	0/51 (0%)	26/51 (51%)
Celecoxib 400 mg	—	0/51 (0%)	19/51 (37.3%)
Placebo	—	0/51 (0%)	29/51 (56.9%)

Most frequent other events

Most frequent other events
Event	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo
NauseaNervous system disorders	8/50	6/51	5/51	12/51
HeadacheNervous system disorders	3/50	4/51	4/51	8/51
Alveolar osteitisGastrointestinal disorders	2/50	5/51	5/51	4/51
Post procedural swellingInjury, poisoning and procedural complications	3/50	5/51	3/51	4/51
VomitingGastrointestinal disorders	2/50	5/51	2/51	2/51
DizzinessNervous system disorders	0/50	2/51	0/51	4/51
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	1/50	4/51	3/51	1/51

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	50	51	51	51	203
>=65 years	0	0	0	0	0

Age Continuous
Age Continuous(years)	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo	Total
Mean	22.0 ± 3.32	22.2 ± 3.81	22.1 ± 3.46	22.1 ± 2.97	22.1 ± 3.38

Sex: Female, Male
Sex: Female, Male(Participants)	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo	Total
Female	32	31	34	35	132
Male	18	20	17	16	71

Region of Enrollment
Region of Enrollment(participants)	Indomethacin Test (Lower Dose)	Indomethacin Test (Upper Dose)	Celecoxib 400 mg	Placebo	Total
United States	50	51	51	51	203

Study locations

1 site

Premier Research Group Limited
Austin, Texas 78705, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00964431
Lead sponsor: Iroko Pharmaceuticals, LLC
Responsible party: Sponsor
First posted: Aug 25, 2009
Start date: Aug 2009
Primary completion: Dec 2009
Completion: Dec 2009
Results posted: Mar 30, 2012
Last update: May 22, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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