Trial Outcomes & Findings for Hormone Function in Men Treated for Pain With Opioids or Placebo (NCT NCT00737737)

NCT ID: NCT00737737

Last Updated: 2015-04-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2015-04-29

Participant Flow

This study enrolled patients with osteoarthritis at the National Institutes of Health Clinical Center. The last patient completed the study in 2012.

A total of 8 patients were enrolled in the study. Three patients did not qualify for the study, 1 patient elected to withdraw from the study to undergo joint surgery prior to receiving study drug and 4 patients completed the study.

Participant milestones

Measure	Opioid Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg MS Contin	Placebo Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hormone Function in Men Treated for Pain With Opioids or Placebo

Baseline characteristics by cohort

Measure	Opioid n=2 Participants Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg MS Contin	Placebo n=2 Participants Participants will receive a similar number of matched placebo tablets over a period of 4 weeks	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Opioid n=2 Participants Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg MS Contin	Placebo n=2 Participants Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?	NA ng/ml Questionable data due to degradation of proteins to be analyzed	NA ng/ml Questionable data due to degradation of proteins to be analyzed

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Opioid n=2 Participants Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg MS Contin	Placebo n=2 Participants Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?	NA ng/ml Questionable data due to degradation of proteins being analyzed	NA ng/ml Questionable data due to degradation of proteins being analyzed

Adverse Events

Opioid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Andrew Mannes, M.D.

National Institutes of Health Clinical Center

Phone: 301-594-3427

Email: Andrew.Mannes@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place