CompletedNCT00977197Updated Oct 28, 2016Results posted

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

A Phase 2 interventional study of Pregabalin and Placebo in Irritable Bowel Syndrome, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 85
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Irritable Bowel Syndrome

Browse trials for

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 85 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: 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

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)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 85 participants (actual)

Study arms

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
Placebo comparator
Placebo
Subjects randomized to this arm will receive placebo matching the study drug.
Drug: Placebo

Interventions

DrugPregabalin
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.
Also known as: Lyrica
DrugPlacebo
A matching placebo will be administered twice a day

What researchers measure

Primary outcomes

Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (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.
Time frame: weeks 9-12

Secondary outcomes

Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (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.
Time frame: weeks 9-12
Mean Constipation BSS Score Over Last 4 Weeks of Study (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.
Time frame: Weeks 9-12
Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (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.
Time frame: Weeks 9-12
Mean Bloating BSS Score Over the Last 4 Weeks of the Study (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.
Time frame: Weeks 9-12)
Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
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
Mean Pain BSS Score at 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.
Time frame: Week 12
Mean Overall Severity BSS Score at 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.
Time frame: Week 12
Mean Constipation BSS Score at 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.
Time frame: Week 12
Mean Diarrhea BSS Score at 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.
Time frame: Week 12
Mean Bloating BSS Score at 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.
Time frame: Week 12
Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
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

Results

Posted Jul 14, 2016

Participant flow

Participant flow — Overall Study
Milestone	Pregabalin	Placebo
Started	41	44
Completed	32	35
Not completed	9	9
Withdrew: Withdrawal by subject	3	4
Withdrew: Adverse event	3	1
Withdrew: Lack of efficacy	1	0
Withdrew: Lost to follow-up	1	3
Withdrew: Nonadherence	1	1

Outcome measures

PrimaryMean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (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.

Time frame:: weeks 9-12
Reported as:: Mean · units on a scale

Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
units on a scale	Pregabalin	Placebo
Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)	25.3 ± 16.0	42.0 ± 26.6

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.008Intent to Treat analysis; adjusted for age and gender.

SecondaryMean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)

Time frame:: weeks 9-12
Reported as:: Mean · units on a scale

Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
units on a scale	Pregabalin	Placebo
Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)	26.5 ± 15.2	42.2 ± 25.7

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.009Intent to Treat analysis; adjusted for age and gender.

SecondaryMean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)

Time frame:: Weeks 9-12
Reported as:: Mean · units on a scale

Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)
units on a scale	Pregabalin	Placebo
Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)	25.8 ± 26.8	22.4 ± 24.8

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.389Intent to Treat analysis; adjusted for age and gender; rank scale.

SecondaryMean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)

Time frame:: Weeks 9-12
Reported as:: Mean · units on a scale

Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
units on a scale	Pregabalin	Placebo
Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)	16.9 ± 18.4	31.8 ± 25.8

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.049Intent to Treat analysis; adjusted for age and gender, rank scale.

SecondaryMean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)

Time frame:: Weeks 9-12)
Reported as:: Mean · units on a scale

Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
units on a scale	Pregabalin	Placebo
Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)	29.3 ± 23.3	43.6 ± 29.0

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.044Intent to Treat analysis; adjusted for age and gender.

SecondaryNumber of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy

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
Reported as:: Number · participants

Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
participants	Pregabalin	Placebo
Adequate Relief (Yes)	19	16
Inadequate Relief (No)	22	28

Statistical analysis

Pregabalin vs Placebo · Chi-squared · p = 0.350 (Intent to treat analysis, not adjusted for age and gender.)

SecondaryMean Pain BSS Score at Week 12

Time frame:: Week 12
Reported as:: Mean · units on a scale

Mean Pain BSS Score at Week 12
units on a scale	Pregabalin	Placebo
Mean Pain BSS Score at Week 12	26.1 ± 18.8	43.3 ± 30

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.020Intent to Treat analysis; adjusted for age and gender, rank scale.

SecondaryMean Overall Severity BSS Score at Week 12

Time frame:: Week 12
Reported as:: Mean · units on a scale

Mean Overall Severity BSS Score at Week 12
units on a scale	Pregabalin	Placebo
Mean Overall Severity BSS Score at Week 12	28.5 ± 20.2	44.2 ± 28.8

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.024Intent to Treat analysis; adjusted for age and gender.

SecondaryMean Constipation BSS Score at Week 12

Time frame:: Week 12
Reported as:: Mean · units on a scale

Mean Constipation BSS Score at Week 12
units on a scale	Pregabalin	Placebo
Mean Constipation BSS Score at Week 12	26.1 ± 30.4	23.6 ± 26.7

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.417Intent to Treat analysis; adjusted for age and gender, rank scale.

SecondaryMean Diarrhea BSS Score at Week 12

Time frame:: Week 12
Reported as:: Mean · units on a scale

Mean Diarrhea BSS Score at Week 12
units on a scale	Pregabalin	Placebo
Mean Diarrhea BSS Score at Week 12	15.6 ± 19.8	34.4 ± 29.7

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.030 (Intent to Treat analysis; adjusted for age and gender, rank scale.)

SecondaryMean Bloating BSS Score at Week 12

Time frame:: Week 12
Reported as:: Mean · units on a scale

Mean Bloating BSS Score at Week 12
units on a scale	Pregabalin	Placebo
Mean Bloating BSS Score at Week 12	26.3 ± 24.4	45.0 ± 32.0

Statistical analysis

Pregabalin vs Placebo · ANCOVA · p = 0.016Intent to Treat analysis; adjusted for age and gender.

SecondaryNumber of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score

Time frame:: baseline, week 12
Reported as:: Number · participants

Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
participants	Pregabalin	Placebo
Yes, >= 30 point change	26	20
No, >= 30 point change	15	24

Statistical analysis

Pregabalin vs Placebo · Chi-squared · p = 0.097 (Intent to Treat analysis; not adjusted for age and gender.)

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pregabalin	—	1/41 (2.4%)	28/41 (68.3%)
Placebo	—	0/44 (0%)	24/44 (54.5%)

Most frequent serious events

Most frequent serious events
Event	Pregabalin	Placebo
External TraumaSocial circumstances	1/41	0/44

Most frequent other events

Showing 10 of 58

Most frequent other events
Event	Pregabalin	Placebo
DizzyNervous system disorders	13/41	2/44
Abdominal painGastrointestinal disorders	13/41	13/44
ConstipationGastrointestinal disorders	9/41	4/44
DiarrheaGastrointestinal disorders	6/41	7/44
TiredGeneral disorders	6/41	5/44
HeadacheNervous system disorders	6/41	5/44
Blurred VisionEye disorders	6/41	1/44
NauseaGastrointestinal disorders	6/41	2/44
BloatingGastrointestinal disorders	4/41	5/44
Pain in lower chestMusculoskeletal and connective tissue disorders	4/41	0/44

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Pregabalin	Placebo	Total
<=18 years	1	2	3
Between 18 and 65 years	38	40	78
>=65 years	2	2	4

Sex: Female, Male
Sex: Female, Male(Participants)	Pregabalin	Placebo	Total
Female	36	37	73
Male	5	7	12

Region of Enrollment
Region of Enrollment(participants)	Pregabalin	Placebo	Total
United States	41	44	85

Number of Subjects with Fibromyalgia at Baseline
Number of Subjects with Fibromyalgia at Baseline(participants)	Pregabalin	Placebo	Total
Fibromyalgia - No	31	37	68
Fibromyalgia - Yes	10	7	17

Study locations

2 sites

Mayo Clinic
Rochester, Minnesota 55905, United States
Mayo Clinic Health System - Franciscan Healthcare in La Crosse
La Crosse, Wisconsin 54601, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00977197
Lead sponsor: Mayo Clinic
Collaborators: Pfizer
Responsible party: Yuri A. Saito Loftus (PI, Mayo Clinic) — Principal investigator
First posted: Sep 15, 2009
Start date: Mar 2010
Primary completion: Jun 2015
Completion: Jun 2015
Results posted: Jul 14, 2016
Last update: Oct 28, 2016

Study contacts

Yuri A Saito Loftus, MD

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Irritable Bowel Syndrome→

Other studies from this sponsor

Mayo Clinic

Start the discussion

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

Study summary

Conditions studied

Browse trials for

In context

Irritable Bowel Syndrome

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria