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Attenuation of Pain in Men and Women

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: NCT01220414
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Pain
Interventions: Drug: Naltrexone, then placebo
Drug: Placebo, then Naltrexone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Males, Naltrexone Then Placebo No text entered.
Males, Placebo Then Naltrexone No text entered.
Females, Naltrexone Then Placebo No text entered.
Females, Placebo Then Naltrexone No text entered.

Participant Flow:   Overall Study
    Males, Naltrexone Then Placebo   Males, Placebo Then Naltrexone   Females, Naltrexone Then Placebo   Females, Placebo Then Naltrexone
STARTED   15   14   14   15 
COMPLETED   14   14   14   14 
NOT COMPLETED   1   0   0   1 
Withdrawal by Subject                1                0                0                1 



  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.
No text entered.

Reporting Groups
  Description
Naltrexone Then Placebo All participants completed both naltrexone and placebo conditions
Placebo Then Naltrxone No text entered.
Total Total of all reporting groups

Baseline Measures
   Naltrexone Then Placebo   Placebo Then Naltrxone   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   29   58 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      29 100.0%      29 100.0%      58 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 21  (3)   21  (3)   21  (3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  48.3%      15  51.7%      29  50.0% 
Male      15  51.7%      14  48.3%      29  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   29   29   58 


  Outcome Measures

1.  Primary:   Time for Subject to Reach Pain Threshold   [ Time Frame: Baseline ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kelli F. Koltyn
Organization: University of Wisconsin-Madison
phone: 608 262-4234
e-mail: kelli.koltyn@wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01220414     History of Changes
Other Study ID Numbers: H-2010-0087
First Submitted: September 28, 2010
First Posted: October 13, 2010
Results First Submitted: December 7, 2015
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018