Trial Outcomes & Findings for Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity (NCT NCT00947284)
NCT ID: NCT00947284
Last Updated: 2016-05-20
Results Overview
Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
TERMINATED
NA
3 participants
Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration
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 |
Women-all Three Combinations
the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
|
Men-all Three Combinations
the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
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|---|---|---|
|
Overall Study
STARTED
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0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
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0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity
Baseline characteristics by cohort
| Measure |
Men-all Three Combinations
n=3 Participants
the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
|
|---|---|
|
Age, Customized
Unknown
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
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3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administrationPopulation: The planned model of skin irritation could not be reproduced on 3 enrolled participants, thus the investigator did not obtain outcome data.
Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
Outcome data not reported
Adverse Events
Men-all Three Combinations
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