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A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00977197
First Posted: September 15, 2009
Last Update Posted: October 28, 2016
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
Results First Submitted: June 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome
Interventions: Drug: Pregabalin
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pregabalin

Subjects randomized to this arm will receive the following dosage:

75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.

Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.

Placebo

Subjects randomized to this arm will receive placebo matching the study drug.

Placebo: A matching placebo will be administered twice a day


Participant Flow:   Overall Study
    Pregabalin   Placebo
STARTED   41   44 
COMPLETED   32   35 
NOT COMPLETED   9   9 
Withdrawal by Subject                3                4 
Adverse Event                3                1 
Lack of Efficacy                1                0 
Lost to Follow-up                1                3 
Nonadherence                1                1 



  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

Subjects randomized to this arm will receive the following dosage:

75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.

Placebo Subjects randomized to this arm will receive placebo matching the study drug.
Total Total of all reporting groups

Baseline Measures
   Pregabalin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   44   85 
Age 
[Units: Participants]
     
<=18 years   1   2   3 
Between 18 and 65 years   38   40   78 
>=65 years   2   2   4 
Gender 
[Units: Participants]
     
Female   36   37   73 
Male   5   7   12 
Region of Enrollment 
[Units: Participants]
     
United States   41   44   85 
Number of Subjects with Fibromyalgia at Baseline 
[Units: Participants]
     
Fibromyalgia - No   31   37   68 
Fibromyalgia - Yes   10   7   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)   [ Time Frame: weeks 9-12 ]

2.  Secondary:   Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)   [ Time Frame: weeks 9-12 ]

3.  Secondary:   Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)   [ Time Frame: Weeks 9-12 ]

4.  Secondary:   Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)   [ Time Frame: Weeks 9-12 ]

5.  Secondary:   Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)   [ Time Frame: Weeks 9-12) ]

6.  Secondary:   Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy   [ Time Frame: Weeks 9-12 ]

7.  Secondary:   Mean Pain BSS Score at Week 12   [ Time Frame: Week 12 ]

8.  Secondary:   Mean Overall Severity BSS Score at Week 12   [ Time Frame: Week 12 ]

9.  Secondary:   Mean Constipation BSS Score at Week 12   [ Time Frame: Week 12 ]

10.  Secondary:   Mean Diarrhea BSS Score at Week 12   [ Time Frame: Week 12 ]

11.  Secondary:   Mean Bloating BSS Score at Week 12   [ Time Frame: Week 12 ]

12.  Secondary:   Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score   [ Time Frame: baseline, week 12 ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Yuri A. Saito Loftus, M.D.
Organization: Mayo Clinic
phone: 507-284-2687
e-mail: saito.yuri@mayo.edu



Responsible Party: Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00977197     History of Changes
Other Study ID Numbers: 09-004404
First Submitted: September 11, 2009
First Posted: September 15, 2009
Results First Submitted: June 6, 2016
Results First Posted: July 14, 2016
Last Update Posted: October 28, 2016