CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
Nortriptyline Oral Capsule +3 moredrug
Likely dose
Nortriptyline titrated from 25 mg once daily at bedtime to maximum 150 mg once daily at bedtime based on response and tolerability; Benztropine titrated from 0.125 mg to 0.750 mg once daily at bedtimeAI-extracted
Key inclusion· 3
  • ✓Age 18 to 65 years
  • ✓TMD-related pain for at least 3 months duration
  • ✓TMD pain is the primary pain condition if other pain conditions are present
Key exclusion· 14
  • ✕Severe TMD with non-reducing disc displacement preventing mouth opening
  • ✕Unstable or acute severe pain from another pain condition
  • ✕Pregnant
  • ✕Angle-closure glaucoma or symptomatic orthosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00066937
NCT00066937Phase 2Completed
CompareCT.gov

Pain Management in Temporomandibular Joint Disorders

Johns Hopkins University·interventional·Posted Aug 8, 2003·Updated Jul 24, 2017

In Brief

A Phase 2 clinical trial evaluating Nortriptyline Oral Capsule, Benztropine Oral Product, and 2 other interventions for Temporomandibular Joint Disorders. Completed, enrolled 140 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTemporomandibular Joint Disorders
CountriesUnited States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2003
Enrollment StartNov 1, 2002
Primary CompletionJun 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 22.9 years ago

Interventions

Nortriptyline Oral Capsuledrug

Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.

Benztropine Oral Productdrug

Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.

CBTbehavioral

Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.

Disease MGTbehavioral

Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.