Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00977197
First received: September 11, 2009
Last updated: July 19, 2016
Last verified: July 2016
Results First Received: June 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome
Interventions: Drug: Pregabalin
Drug: Placebo

  Participant Flow
  Hide 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
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
  Hide 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
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  
Number of Participants  
[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
  Hide 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
  Hide More Information

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
Study First Received: September 11, 2009
Results First Received: June 6, 2016
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration