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NCT02437383 · ClinicalTrials.gov registry record · Phase 2
Study of Orofacial Pain and PropRANOlol
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT02437383 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 200 participants.
The verdict
NCT02437383, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Purpose: Primary: To evaluate the efficacy of extended-release (ER) propranolol compared to placebo in the reduction of a pain index in patients with temporomandibular disorder (TMD). Secondary: To determine if extended-release propranolol efficacy varies according to participants' catechol-O-methyltransferase (COMT) genetic polymorphisms and to investigate the efficacy of extended-release propranolol compared with placebo using secondary endpoints. Exploratory: To investigate whether the efficacy of extended-release propranolol in the reduction of the pain index varies according to participants' polymorphisms in 3 other genetic regions and according to various phenotypic characteristics. Participants: 200 patients with chronic TMD will be randomly assigned, in a 1:1 parallel, double-blind fashion, to receive either extended-release propranolol or placebo at one of three study sites: University of North Carolina-Chapel Hill School of Dentistry; University of Florida-Gainesville College of Dentistry; and the State University of New York at Buffalo School of Dental Medicine. Procedures (methods): Randomization will be to either propranolol or placebo. The 10-week study treatment period is divided into: 1 week of drug titration, 8 weeks of drug maintenance, and 1 week of drug tapering. The titration and tapering doses are 60 mg (capsules) once per day orally; the maintenance dose is 60 mg twice per day orally. Participants will attend 6 clinic visits over 12-15 weeks as follows: screening and baseline visit (Visit \[V\] 0, 7-21 days prior to V1); randomization and start of treatment (titration) (V1, study day 0); maintenance visit 2 (V2, 1 week post-randomization, study day 7+3); maintenance visit 3 (V3, 5 weeks post-randomization, study day 35 +/- 7); tapering visit (V4, 9 weeks post-randomization, study day 63 +/- 7); and tapering visit 5 (V5, 11 weeks post-randomization and 1 week after drug tapering ends, study day 77 +/- 7). Depending on the visit, procedur
Interventions
- DRUG Placebo
- DRUG Propranolol ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2015-08-20 |
| Est. Completion | 2018-04-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02437383
The ClinicalTrials.gov registry entry for NCT02437383 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02437383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02437383 about?
NCT02437383 is a clinical study titled "Study of Orofacial Pain and PropRANOlol". Purpose: Primary: To evaluate the efficacy of extended-release (ER) propranolol compared to placebo in the reduction of a pain index in patients with temporomandibular disorder (TMD). Secondary: To determine if extended-release propranolol efficacy varies according to participants' catechol-O-meth...
What is the current status of trial NCT02437383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2015-08-20. Estimated completion is 2018-04-25.
What interventions are being tested in trial NCT02437383?
The interventions under investigation include: Placebo (DRUG), Propranolol ER (DRUG).
Who is sponsoring clinical trial NCT02437383?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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