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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00977197
• Collaborator: Pfizer (Industry)
• Enrollment: 85
• Locations: 2
• Arms: 2
• Duration (Months): 63
• Patients Per Site: 42.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study is being done to see if Lyrica helps people with irritable bowel syndrome.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Drug: Pregabalin; Drug: Placebo	Phase 2

Detailed Description

Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including irritable bowel syndrome-related conditions such as fibromyalgia.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Lyrica
Placebo Comparator: Placebo Subjects randomized to this arm will receive placebo matching the study drug.	Drug: Placebo; A matching placebo will be administered twice a day

Outcome Measures

Primary Outcome Measures

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

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

Secondary Outcome Measures

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

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

2. Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) [Weeks 9-12]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

3. Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) [Weeks 9-12]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

4. Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) [Weeks 9-12)]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

5. Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy [Weeks 9-12]

   One of the weekly questions asked of subjects was, "Did you have adequate relief of your IBS symptoms over the last week?" Possible answers were Yes or No.

6. Mean Pain BSS Score at Week 12 [Week 12]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

7. Mean Overall Severity BSS Score at Week 12 [Week 12]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

8. Mean Constipation BSS Score at Week 12 [Week 12]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

9. Mean Diarrhea BSS Score at Week 12 [Week 12]

   The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

10. Mean Bloating BSS Score at Week 12 [Week 12]

    The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

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

    The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Established diagnosis of Irritable Bowel Syndrome (IBS)

• Experience pain with relief with defecation

• 50/100 or greater of pain or discomfort scores during the two-week baseline period

• At least three pain attacks in a month, with at least three episodes of pain intensity equal to or exceeding 50/100

• U.S. resident

• English-speaking (able to provide consent and complete questionnaires)

• Able to participate in all aspects of the study

Exclusion Criteria:

• Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, active celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, active pelvic floor dysfunction, paraplegia or quadriplegia);

• Current symptoms of severe depression, as measured by Hospital Anxiety and Depression Scale (HADS) score (greater or less than 15);

• Mental retardation or any condition requiring a legal guardian;

• Current or past history of psychotic disorder (schizophrenia, bipolar disorder)

• Recent or current use (within past 30 days) of drugs that interact with Pregabalin:

• Rosiglitazone (Avandia) or Pioglitazone (Actos)

• Narcotic anti-pain medications (e.g. oxycodone, morphine)

• Anti-anxiety medications (e.g. lorazepam, alprazolam, diazepam)

• Unable to withdraw medications at least 72 hours prior to the study, because we will evaluate patient's response to pregabalin therapy for relief of IBS-associated pain and disturbed sleep.

1. Non-narcotic anti-pain medications (e.g. nonsteroidal antiinflammatory drug (NSAIDs), ultram, neurontin, etc.)

2. Mexiletine, steroids, dextromethorphan.

3. Insomnia medications (e.g. benzodiazepines, zolpidem, diphenhydramine, melatonin, etc.)

• Planned surgery (especially transplant) or anesthesia exposure during trial

• Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, or abstinence)

• Recent or current use (within 30 days) of Pregabalin

• Known allergy to Pregabalin

• Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease

• Recent history of alcohol or substance dependence use or abuse

• Another household member or relative participating in the study

• Professional drivers or operators of heavy machinery

• Major cardiovascular events in the last 6 months

• Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)

• Participation in another clinical trial (within 30 days)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	Mayo Clinic Health System - Franciscan Healthcare in La Crosse	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

• Mayo Clinic
• Pfizer

Investigators

• Principal Investigator: Yuri A Saito Loftus, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuri A. Saito Loftus, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00977197
• Other Study ID Numbers: 09-004404
• First Posted: Sep 15, 2009
• Last Update Posted: Oct 28, 2016
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Pregabalin

Study Results

Participant Flow

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug. Placebo: A matching placebo will be administered twice a day
Period Title: Overall Study
STARTED	41	44
COMPLETED	32	35
NOT COMPLETED	9	9

Baseline Characteristics

Arm/Group Title	Pregabalin	Placebo	Total
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.	Total of all reporting groups
Overall Participants	41	44	85
Age (Count of Participants)
<=18 years	1 2.4%	2 4.5%	3 3.5%
Between 18 and 65 years	38 92.7%	40 90.9%	78 91.8%
>=65 years	2 4.9%	2 4.5%	4 4.7%
Sex: Female, Male (Count of Participants)
Female	36 87.8%	37 84.1%	73 85.9%
Male	5 12.2%	7 15.9%	12 14.1%
Region of Enrollment (participants) [Number]
United States	41 100%	44 100%	85 100%
Number of Subjects with Fibromyalgia at Baseline (participants) [Number]
Fibromyalgia - No	31 75.6%	37 84.1%	68 80%
Fibromyalgia - Yes	10 24.4%	7 15.9%	17 20%

Outcome Measures

1. Primary Outcome

Title	Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	weeks 9-12

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	41	44
Mean (Standard Deviation) [units on a scale]	25.3 (16.0)	42.0 (26.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender.

2. Secondary Outcome

Title	Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	weeks 9-12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	35
Mean (Standard Deviation) [units on a scale]	26.5 (15.2)	42.2 (25.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender.

3. Secondary Outcome

Title	Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Weeks 9-12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	35
Mean (Standard Deviation) [units on a scale]	25.8 (26.8)	22.4 (24.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.389
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender; rank scale.

4. Secondary Outcome

Title	Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Weeks 9-12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	35
Mean (Standard Deviation) [units on a scale]	16.9 (18.4)	31.8 (25.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.049
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender, rank scale.

5. Secondary Outcome

Title	Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Weeks 9-12)

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	35
Mean (Standard Deviation) [units on a scale]	29.3 (23.3)	43.6 (29.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender.

6. Secondary Outcome

Title	Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
Description	One of the weekly questions asked of subjects was, "Did you have adequate relief of your IBS symptoms over the last week?" Possible answers were Yes or No.
Time Frame	Weeks 9-12

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	41	44
Adequate Relief (Yes)	19 46.3%	16 36.4%
Inadequate Relief (No)	22 53.7%	28 63.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.350
	Comments	Intent to treat analysis, not adjusted for age and gender.
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Mean Pain BSS Score at Week 12
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	34
Mean (Standard Deviation) [units on a scale]	26.1 (18.8)	43.3 (30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender, rank scale.

8. Secondary Outcome

Title	Mean Overall Severity BSS Score at Week 12
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	34
Mean (Standard Deviation) [units on a scale]	28.5 (20.2)	44.2 (28.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender.

9. Secondary Outcome

Title	Mean Constipation BSS Score at Week 12
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	34
Mean (Standard Deviation) [units on a scale]	26.1 (30.4)	23.6 (26.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.417
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender, rank scale.

10. Secondary Outcome

Title	Mean Diarrhea BSS Score at Week 12
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	34
Mean (Standard Deviation) [units on a scale]	15.6 (19.8)	34.4 (29.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	Intent to Treat analysis; adjusted for age and gender, rank scale.
	Method	ANCOVA
	Comments

11. Secondary Outcome

Title	Mean Bloating BSS Score at Week 12
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	29	34
Mean (Standard Deviation) [units on a scale]	26.3 (24.4)	45.0 (32.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	ANCOVA
	Comments	Intent to Treat analysis; adjusted for age and gender.

12. Secondary Outcome

Title	Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
Description	The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time Frame	baseline, week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat analysis

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	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.	Subjects randomized to this arm will receive placebo matching the study drug.
Measure Participants	41	44
Yes, >= 30 point change	26 63.4%	20 45.5%
No, >= 30 point change	15 36.6%	24 54.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.097
	Comments	Intent to Treat analysis; not adjusted for age and gender.
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	1 year
Arm/Group Title	Pregabalin		Placebo
Arm/Group Description	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.		Subjects randomized to this arm will receive placebo matching the study drug.
All Cause Mortality
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/41 (2.4%)		0/44 (0%)
Social circumstances
External Trauma	1/41 (2.4%)	1	0/44 (0%)	0
Other (Not Including Serious) Adverse Events
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/41 (68.3%)		24/44 (54.5%)
Cardiac disorders
Heart racing	1/41 (2.4%)	1	0/44 (0%)	0
Blood pressure increased	0/41 (0%)	0	1/44 (2.3%)	1
Eye disorders
Blurred Vision	6/41 (14.6%)	6	1/44 (2.3%)	1
Dry eyes	1/41 (2.4%)	2	1/44 (2.3%)	1
Gastrointestinal disorders
Diarrhea	6/41 (14.6%)	7	7/44 (15.9%)	11
Dry mouth	1/41 (2.4%)	1	1/44 (2.3%)	1
Abdominal pain	13/41 (31.7%)	15	13/44 (29.5%)	17
Bloating	4/41 (9.8%)	4	5/44 (11.4%)	6
Upset stomach	4/41 (9.8%)	7	1/44 (2.3%)	1
Constipation	9/41 (22%)	11	4/44 (9.1%)	4
Mucus in bowel movement	2/41 (4.9%)	4	0/44 (0%)	0
Hemorrhoids	2/41 (4.9%)	2	0/44 (0%)	0
Nausea	6/41 (14.6%)	6	2/44 (4.5%)	2
Abdominal gas	4/41 (9.8%)	4	4/44 (9.1%)	5
Fullness in the abdomen	2/41 (4.9%)	2	0/44 (0%)	0
Burping	1/41 (2.4%)	1	1/44 (2.3%)	1
More bowel movements than usual	2/41 (4.9%)	2	2/44 (4.5%)	2
Loss of appetite	0/41 (0%)	0	1/44 (2.3%)	1
Excessive thirst	0/41 (0%)	0	1/44 (2.3%)	1
Urgency to defecate	0/41 (0%)	0	1/44 (2.3%)	1
Change in appearance of stool	0/41 (0%)	0	3/44 (6.8%)	3
Vomiting	0/41 (0%)	0	1/44 (2.3%)	1
General disorders
Insomnia	1/41 (2.4%)	1	1/44 (2.3%)	1
Tired	6/41 (14.6%)	9	5/44 (11.4%)	5
Weight gain	1/41 (2.4%)	1	0/44 (0%)	0
Restless at night	1/41 (2.4%)	1	0/44 (0%)	0
Body aches	1/41 (2.4%)	1	0/44 (0%)	0
Chills	1/41 (2.4%)	1	0/44 (0%)	0
Stress	1/41 (2.4%)	1	2/44 (4.5%)	2
Fever	1/41 (2.4%)	1	0/44 (0%)	0
Pain over all body	0/41 (0%)	0	1/44 (2.3%)	1
Increased hunger	0/41 (0%)	0	1/44 (2.3%)	1
Vivid dreams	0/41 (0%)	0	1/44 (2.3%)	1
Loss of nails	0/41 (0%)	0	1/44 (2.3%)	2
Infections and infestations
Flu like symptoms	1/41 (2.4%)	1	1/44 (2.3%)	1
Bladder infection	0/41 (0%)	0	1/44 (2.3%)	1
Musculoskeletal and connective tissue disorders
Pain in lower chest	4/41 (9.8%)	4	0/44 (0%)	0
Cramping right side	1/41 (2.4%)	1	0/44 (0%)	0
Back pain	1/41 (2.4%)	1	3/44 (6.8%)	3
Leg cramps	1/41 (2.4%)	1	0/44 (0%)	0
Pain in upper right chest	0/41 (0%)	0	2/44 (4.5%)	2
Muscle pain rib cage right side	0/41 (0%)	0	1/44 (2.3%)	1
Pain lower left side	0/41 (0%)	0	1/44 (2.3%)	1
Fingers swelling	0/41 (0%)	0	1/44 (2.3%)	1
Foot peripheral edema	0/41 (0%)	0	1/44 (2.3%)	1
Gout in arches of feet	0/41 (0%)	0	1/44 (2.3%)	1
Muscle twitching in upper back	0/41 (0%)	0	1/44 (2.3%)	1
Nerve pain down arms and legs	0/41 (0%)	0	1/44 (2.3%)	2
Nervous system disorders
Headache	6/41 (14.6%)	6	5/44 (11.4%)	5
Dizzy	13/41 (31.7%)	20	2/44 (4.5%)	2
Migraine	2/41 (4.9%)	2	1/44 (2.3%)	1
Feeling of being high or tipsy	4/41 (9.8%)	6	0/44 (0%)	0
Psychiatric disorders
Depression	0/41 (0%)	0	1/44 (2.3%)	1
Reproductive system and breast disorders
No libido	0/41 (0%)	0	1/44 (2.3%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms	1/41 (2.4%)	1	0/44 (0%)	0
Skin and subcutaneous tissue disorders
Paresthesia (tingling) of the fingers	1/41 (2.4%)	1	0/44 (0%)	0
Rash	2/41 (4.9%)	2	0/44 (0%)	0
Itch	1/41 (2.4%)	1	0/44 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.