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Hormone Function in Men Treated for Pain With Opioids or Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737737
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Pain
Osteoarthritis
Interventions Drug: MS Contin
Drug: Placebo
Enrollment 8
Recruitment Details This study enrolled patients with osteoarthritis at the National Institutes of Health Clinical Center. The last patient completed the study in 2012.
Pre-assignment Details 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.
Arm/Group Title Opioid Placebo
Hide Arm/Group Description

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

Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Opioid Placebo Total
Hide Arm/Group Description

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

Participants will receive a similar number of matched placebo tablets over a period of 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
2
 100.0%
4
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  50.0%
1
  25.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
1
  50.0%
3
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opioid Placebo
Hide Arm/Group Description:

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

Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: ng/ml
NA [1]  NA [1] 
[1]
Questionable data due to degradation of proteins to be analyzed
2.Secondary Outcome
Title Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opioid Placebo
Hide Arm/Group Description:

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

Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: ng/ml
NA [1]  NA [1] 
[1]
Questionable data due to degradation of proteins being analyzed
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Opioid Placebo
Hide Arm/Group Description

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

Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
All-Cause Mortality
Opioid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Opioid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Opioid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Mannes, M.D.
Organization: National Institutes of Health Clinical Center
Phone: 301-594-3427
EMail: Andrew.Mannes@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT00737737    
Other Study ID Numbers: 080190
08-NR-0190
First Submitted: August 16, 2008
First Posted: August 20, 2008
Results First Submitted: April 9, 2015
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015