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NCT04059172 · ClinicalTrials.gov registry record · Early Phase 1
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
A Early Phase 1 study of Pain, Orofacial, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 375
- Enrollment target
- 1
- Study location
NCT04059172: Recruiting Early Phase 1 study of Pain, Orofacial, sponsored by University of Colorado, Denver.
NCT04059172 is a Early Phase 1 study of Pain, Orofacial that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 375 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (608% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04059172, a Early Phase 1 study of Pain, Orofacial, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 375 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
Primary Outcome
Primary outcomes with be the pain values recorded by subjects when chewing on the 100-mm VAS at set times.The VAS line for each time period will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right.
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Ibuprofen 200 mg and acetaminphen 650 mg
- DRUG Ibuprofen 200 mg
Study Locations (1)
Colorado
- University of Colorado, School of Dental Medicine - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2019-12-10 |
| Est. Completion | 2028-01-01 |
| Phase | Early Phase 1 |
What NCT04059172 shows while recruiting
NCT04059172 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (608% higher).
The record links to 1 condition, with Pain, Orofacial appearing as the primary indexed condition, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04059172 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04059172 about?
NCT04059172 is a clinical study titled "Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management". The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen ther...
What is the current status of trial NCT04059172?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 375 participants. The study started on 2019-12-10. Estimated completion is 2028-01-01.
What conditions does trial NCT04059172 study?
This clinical trial studies the following conditions: Pain, Orofacial.
What interventions are being tested in trial NCT04059172?
The interventions under investigation include: Placebo oral tablet (DRUG), Ibuprofen 200 mg and acetaminphen 650 mg (DRUG), Ibuprofen 200 mg (DRUG).
Who is sponsoring clinical trial NCT04059172?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04059172 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04059172's enrollment target sits among peer trials
375 28th of 2000 higher than 1,973 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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