Trial Outcomes & Findings for Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain (NCT NCT00716807)
NCT ID: NCT00716807
Last Updated: 2016-05-20
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
20 minute intervals for three hours.
Results posted on
2016-05-20
Participant Flow
Recruitment details unavailable due to death of investigator
pre-assignment details unavailable due to death of investigator
Participant milestones
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
18
|
15
|
|
Overall Study
COMPLETED
|
8
|
5
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
Baseline characteristics by cohort
| Measure |
BMS Nalbuphine + Naloxone
n=8 Participants
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
n=5 Participants
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
n=18 Participants
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
n=15 Participants
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
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Unknown
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
15 participants
n=4 Participants
|
46 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 20 minute intervals for three hours.Population: 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.
Outcome measures
Outcome data not reported
Adverse Events
BMS Nalbuphine + Naloxone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BMS Nalbuphine + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TMD Nalbuphine + Naloxone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TMD Nalbuphine + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place