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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment details unavailable due to death of investigator

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
pre-assignment details unavailable due to death of investigator

Reporting Groups
  Description
BMS Nalbuphine + Naloxone 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).
BMS Nalbuphine + Placebo 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).
TMD Nalbuphine + Naloxone 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).
TMD Nalbuphine + Placebo 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).

Participant Flow:   Overall Study
    BMS Nalbuphine + Naloxone   BMS Nalbuphine + Placebo   TMD Nalbuphine + Naloxone   TMD Nalbuphine + Placebo
STARTED   8   5   18   15 
COMPLETED   8   5   18   15 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
BMS Nalbuphine + Naloxone 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).
BMS Nalbuphine + Placebo 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).
TMD Nalbuphine + Naloxone 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).
TMD Nalbuphine + Placebo 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 Total of all reporting groups

Baseline Measures
   BMS Nalbuphine + Naloxone   BMS Nalbuphine + Placebo   TMD Nalbuphine + Naloxone   TMD Nalbuphine + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   5   18   15   46 
Age, Customized 
[Units: Participants]
         
Unknown   8   5   18   15   46 
Gender 
[Units: Participants]
         
Female   5   5   15   13   38 
Male   3   0   3   2   8 
Region of Enrollment 
[Units: Participants]
         
United States   8   5   18   15   46 


  Outcome Measures

1.  Primary:   Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.   [ Time Frame: 20 minute intervals for three hours. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: jon.levine@ucsf.edu



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