Trial · NCT00964431
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
NCT00964431, Phase 2, Completed, Iroko Pharmaceuticals, LLC; results first posted 2012-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Indomethacin Capsules to Treat Dental Pain. Trials, record NCT00964431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00964431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
- NCT number
- NCT00964431
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 203 participants, actual
- Lead sponsor
- Iroko Pharmaceuticals, LLC
- Conditions
- Dental Pain
- Interventions
- Celecoxib 400 mg, Placebo, Indomethacin Test (lower dose), Indomethacin Test (upper dose)
- First posted
- 2009-08-25
- Last updated
- 2012-05-22
- Results first posted
- 2012-03-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Patient Pain Relief Over 0 to 8 Hours. | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Patient Pain Relief Over 0 to 8 Hours. | 8 hours | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Patient Pain Relief Over 0 to 8 Hours. | Indomethacin Test (Lower Dose) | 10.794 | 95% Confidence Interval 8.131 to 13.456 | units on a scale | |
| Total Patient Pain Relief Over 0 to 8 Hours. | Indomethacin Test (Upper Dose) | 12.564 | 95% Confidence Interval 9.928 to 15.200 | units on a scale | |
| Total Patient Pain Relief Over 0 to 8 Hours. | Celecoxib 400 mg | 14.822 | 95% Confidence Interval 12.185 to 17.460 | units on a scale | |
| Total Patient Pain Relief Over 0 to 8 Hours. | Placebo | 3.019 | 95% Confidence Interval 0.381 to 5.656 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indomethacin Test (Lower Dose) | 50 | |
| Overall Study | STARTED | Indomethacin Test (Upper Dose) | 51 | |
| Overall Study | STARTED | Celecoxib 400 mg | 51 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | COMPLETED | Indomethacin Test (Lower Dose) | 50 | |
| Overall Study | COMPLETED | Indomethacin Test (Upper Dose) | 51 | |
| Overall Study | COMPLETED | Celecoxib 400 mg | 51 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | Indomethacin Test (Lower Dose) | 0 | |
| Overall Study | NOT COMPLETED | Indomethacin Test (Upper Dose) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alveolar osteitis | Gastrointestinal disorders | Indomethacin Test (Lower Dose) | 2 | 50 | |
| other | Alveolar osteitis | Gastrointestinal disorders | Indomethacin Test (Upper Dose) | 5 | 51 | |
| other | Alveolar osteitis | Gastrointestinal disorders | Celecoxib 400 mg | 5 | 51 | |
| other | Alveolar osteitis | Gastrointestinal disorders | Placebo | 4 | 51 | |
| other | Dizziness | Nervous system disorders | Indomethacin Test (Lower Dose) | 0 | 50 | |
| other | Dizziness | Nervous system disorders | Indomethacin Test (Upper Dose) | 2 | 51 | |
| other | Dizziness | Nervous system disorders | Celecoxib 400 mg | 0 | 51 | |
| other | Dizziness | Nervous system disorders | Placebo | 4 | 51 | |
| other | Headache | Nervous system disorders | Indomethacin Test (Lower Dose) | 3 | 50 | |
| other | Headache | Nervous system disorders | Indomethacin Test (Upper Dose) | 4 | 51 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Indomethacin Test (Lower Dose) | ||
| Total, all-cause mortality | Indomethacin Test (Upper Dose) | ||
| Total, all-cause mortality | Celecoxib 400 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Indomethacin Test (Lower Dose) | 19 | 50 |
| Total, other adverse events | Indomethacin Test (Upper Dose) | 26 | 51 |
| Total, other adverse events | Celecoxib 400 mg | 19 | 51 |
| Total, other adverse events | Placebo | 29 | 51 |
| Total, serious adverse events | Indomethacin Test (Lower Dose) | 0 | 50 |
| Total, serious adverse events | Indomethacin Test (Upper Dose) | 0 | 51 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00964431
GET https://conductscience.org/api/trials/v1/NCT00964431/events?page=2