Trial · NCT01229228
Study of Naproxen Capsules to Treat Dental Pain
NCT01229228, Phase 2, Completed, Iroko Pharmaceuticals, LLC; results first posted 2012-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Naproxen Capsules to Treat Dental Pain. Trials, record NCT01229228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01229228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Naproxen Capsules to Treat Dental Pain
- NCT number
- NCT01229228
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 254 participants, actual
- Lead sponsor
- Iroko Pharmaceuticals, LLC
- Conditions
- Dental Pain
- Interventions
- Naproxen Test, Naproxen Test, Naprosyn, Naprosyn, Placebo
- First posted
- 2010-10-27
- Last updated
- 2012-05-22
- Results first posted
- 2012-03-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Over 0 to 12 Hours | Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint 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. |
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 | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Over 0 to 12 Hours | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Naproxen Test (Lower Dose) | 25.868 | 95% Confidence Interval 21.943 to 29.792 | units on a scale | |
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Naproxen Test (Upper Dose) | 31.948 | 95% Confidence Interval 28.065 to 35.831 | units on a scale | |
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Naprosyn 250 mg | 24.373 | 95% Confidence Interval 20.442 to 28.304 | units on a scale | |
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Naprosyn 500 mg | 28.549 | 95% Confidence Interval 24.660 to 32.439 | units on a scale | |
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Placebo | 9.531 | 95% Confidence Interval 5.646 to 13.416 | units on a scale |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naproxen Test (Lower Dose) | 51 | |
| Overall Study | STARTED | Naproxen Test (Upper Dose) | 51 | |
| Overall Study | STARTED | Naprosyn 250 mg | 50 | |
| Overall Study | STARTED | Naprosyn 500 mg | 51 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | COMPLETED | Naproxen Test (Lower Dose) | 50 | |
| Overall Study | COMPLETED | Naproxen Test (Upper Dose) | 51 | |
| Overall Study | COMPLETED | Naprosyn 250 mg | 49 | |
| Overall Study | COMPLETED | Naprosyn 500 mg | 51 | |
| Overall Study | COMPLETED | Placebo | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events40
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 | Dizziness | Nervous system disorders | Naproxen Test (Lower Dose) | 5 | 51 | |
| other | Dizziness | Nervous system disorders | Naproxen Test (Upper Dose) | 3 | 51 | |
| other | Dizziness | Nervous system disorders | Naprosyn 250 mg | 2 | 50 | |
| other | Dizziness | Nervous system disorders | Naprosyn 500 mg | 0 | 51 | |
| other | Dizziness | Nervous system disorders | Placebo | 6 | 51 | |
| other | Headache | Nervous system disorders | Naproxen Test (Lower Dose) | 5 | 51 | |
| other | Headache | Nervous system disorders | Naproxen Test (Upper Dose) | 6 | 51 | |
| other | Headache | Nervous system disorders | Naprosyn 250 mg | 6 | 50 | |
| other | Headache | Nervous system disorders | Naprosyn 500 mg | 5 | 51 | |
| other | Headache | Nervous system disorders | Placebo | 9 | 51 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naproxen Test (Lower Dose) | ||
| Total, all-cause mortality | Naproxen Test (Upper Dose) | ||
| Total, all-cause mortality | Naprosyn 250 mg | ||
| Total, all-cause mortality | Naprosyn 500 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Naproxen Test (Lower Dose) | 28 | 51 |
| Total, other adverse events | Naproxen Test (Upper Dose) | 27 | 51 |
| Total, other adverse events | Naprosyn 250 mg | 25 | 50 |
| Total, other adverse events | Naprosyn 500 mg | 26 | 51 |
| Total, other adverse events | Placebo | 31 | 51 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24127200 | DERIVED |
Source PubMed
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/NCT01229228
GET https://conductscience.org/api/trials/v1/NCT01229228/events?page=2