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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00716807
Other study ID # NIH/NIDCR R01 DE018526-1
Secondary ID 1R01DE018526-01
Status Terminated
Phase N/A
First received July 14, 2008
Last updated May 19, 2016
Start date January 2008
Est. completion date June 2010

Study information

Verified date October 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.


Recruitment information / eligibility

Status Terminated
Enrollment 46
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of temporomandibular muscle pain OR

- Clinical diagnosis of burning mouth syndrome

- Pain duration: at least 3 months

- Pain severity: 2 or greater on a 0 - 10 scale

Exclusion Criteria:

- No adverse reaction to study drugs

- Not currently using narcotic analgesic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
nalbuphine plus naloxone
Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
nalbuphine plus placebo
Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
nalbuphine plus naloxone
Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
nalbuphine plus placebo
Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. 20 minute intervals for three hours. No
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