Pregabalin and Colonic Function

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01094808
First received: March 24, 2010
Last updated: March 5, 2012
Last verified: March 2012
Results First Received: January 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition: Healthy
Interventions: Drug: Pregabalin
Drug: Placebo
Other: Bowel preparation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between April 2010 and January 2011 at the Mayo Clinic, Rochester, Minnesota.

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
Pregabalin 75 mg Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Pregabalin 200 mg Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Placebo Subjects randomized to this arm received a single dose of placebo medication orally

Participant Flow:   Overall Study
    Pregabalin 75 mg     Pregabalin 200 mg     Placebo  
STARTED     21     20     21  
COMPLETED     20     19     21  
NOT COMPLETED     1     1     0  
Withdrawal by Subject                 1                 1                 0  



  Baseline Characteristics
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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
Pregabalin 75 mg Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
Pregabalin 200 mg Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
Placebo Subjects randomized to this arm received a single dose of placebo medication orally
Total Total of all reporting groups

Baseline Measures
    Pregabalin 75 mg     Pregabalin 200 mg     Placebo     Total  
Number of Participants  
[units: participants]
  21     20     21     62  
Age  
[units: years]
Mean ± Standard Deviation
  32.2  ± 11.9     32.4  ± 9.1     31.6  ± 11.8     32  ± 11  
Gender  
[units: participants]
       
Female     16     15     15     46  
Male     5     5     6     16  
Region of Enrollment  
[units: participants]
       
United States     21     20     21     62  
Body Mass Index (BMI) [1]
[units: kg/m^2]
Mean ± Standard Deviation
  25.8  ± 3.7     26.7  ± 6.3     26.4  ± 4.4     26.3  ± 0.6  
[1] Body mass index is defined as the individual's body weight divided by the square of his or her height.



  Outcome Measures
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1.  Primary:   Sensory Threshold for Pain   [ Time Frame: approximately 60 minutes after drug administration ]

2.  Primary:   Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure   [ Time Frame: Approximately 60 minutes after drug administration ]

3.  Primary:   Colonic Compliance   [ Time Frame: Approximately 60 minutes after drug administration ]

4.  Primary:   Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume   [ Time Frame: The first 30 minutes postprandially, and preprandial (30 minutes) ]

5.  Primary:   Postprandial Motility Index Over 30 Minutes   [ Time Frame: 30 minutes after the meal ]

6.  Secondary:   Sensory Threshold for Gas   [ Time Frame: Approximately 60 minutes after drug administration ]

7.  Secondary:   Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension   [ Time Frame: Approximately 60 minutes after drug administration ]

8.  Secondary:   Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension   [ Time Frame: Approximately 60 minutes after drug administration ]

9.  Secondary:   Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)   [ Time Frame: Approximately 60 minutes after drug administration ]

10.  Secondary:   Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)   [ Time Frame: Approximately 60 minutes after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
phone: 507-266-2305
e-mail: camilleri.michael@mayo.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01094808     History of Changes
Other Study ID Numbers: 09-008469, 1RC1DK086182, R01DK079866, R01DK067071, UL1RR024150
Study First Received: March 24, 2010
Results First Received: January 26, 2012
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board