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Trial record 12 of 19 for:    "Burning Mouth Syndrome"

Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain

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ClinicalTrials.gov Identifier: NCT00716807
Recruitment Status : Terminated (Unable to recruit a sufficient number of subjects.)
First Posted : July 16, 2008
Results First Posted : October 22, 2013
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions Temporomandibular Joint Dysfunction Syndrome
Burning Mouth Syndrome
Interventions Drug: nalbuphine plus naloxone
Drug: nalbuphine plus placebo
Enrollment 46
Recruitment Details Recruitment details unavailable due to death of investigator
Pre-assignment Details pre-assignment details unavailable due to death of investigator
Arm/Group Title BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 8 5 18 15
Completed 8 5 18 15
Not Completed 0 0 0 0
Arm/Group Title BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo Total
Hide Arm/Group Description 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). 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). Total of all reporting groups
Overall Number of Baseline Participants 8 5 18 15 46
Hide Baseline Analysis Population Description
Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Unknown Number Analyzed 8 participants 5 participants 18 participants 15 participants 46 participants
8 5 18 15 46
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 5 participants 18 participants 15 participants 46 participants
Female
5
  62.5%
5
 100.0%
15
  83.3%
13
  86.7%
38
  82.6%
Male
3
  37.5%
0
   0.0%
3
  16.7%
2
  13.3%
8
  17.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 5 participants 18 participants 15 participants 46 participants
8 5 18 15 46
1.Primary Outcome
Title Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
Hide Description [Not Specified]
Time Frame 20 minute intervals for three hours.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.
Arm/Group Title BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Dr. Robert Gear led this study and maintained data on his computer. Co-investigators have spent many hours trying to locate data on the deceased investigators' computer, but could find nothing other than minimal results data that did not include Adverse Event (AE)or SAE data.
 
Arm/Group Title BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo
Hide Arm/Group Description 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). 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).
All-Cause Mortality
BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BMS Nalbuphine + Naloxone BMS Nalbuphine + Placebo TMD Nalbuphine + Naloxone TMD Nalbuphine + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Dr. Robert Gear led this study and maintained data on his computer. Co-investigators have spent many hours trying to locate data on the deceased investigators' computer, but could find nothing other than the minimal results data entered here.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jon Levine MD, PhD
Organization: UCSF
Phone: 415-476-5108
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00716807     History of Changes
Other Study ID Numbers: NIH/NIDCR R01 DE018526-1
1R01DE018526-01 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2008
First Posted: July 16, 2008
Results First Submitted: August 13, 2013
Results First Posted: October 22, 2013
Last Update Posted: May 20, 2016