Trial · NCT00977197
A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
NCT00977197, Phase 2, Completed, Mayo Clinic; results first posted 2016-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome. Trials, record NCT00977197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00977197
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
- NCT number
- NCT00977197
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Pregabalin, Placebo
- First posted
- 2009-09-15
- Last updated
- 2016-10-28
- Results first posted
- 2016-07-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | weeks 9-12 | Intent to treat analysis | units on a scale | MEAN |
| SECONDARY | Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | weeks 9-12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | Weeks 9-12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Weeks 9-12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Weeks 9-12) | 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. | units on a scale | MEAN |
| SECONDARY | Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | Weeks 9-12 | Intent to treat analysis | participants | NUMBER |
| SECONDARY | Mean Pain BSS Score at Week 12 | Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Overall Severity BSS Score at Week 12 | Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Constipation BSS Score at Week 12 | Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Diarrhea BSS Score at Week 12 | Week 12 | 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. | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | Pregabalin | 25.3 | Standard Deviation 16.0 | units on a scale | |
| Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | Placebo | 42.0 | Standard Deviation 26.6 | units on a scale | |
| Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | Pregabalin | 26.5 | Standard Deviation 15.2 | units on a scale | |
| Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | Placebo | 42.2 | Standard Deviation 25.7 | units on a scale | |
| Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | Pregabalin | 25.8 | Standard Deviation 26.8 | units on a scale | |
| Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | Placebo | 22.4 | Standard Deviation 24.8 | units on a scale | |
| Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Pregabalin | 16.9 | Standard Deviation 18.4 | units on a scale | |
| Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Placebo | 31.8 | Standard Deviation 25.8 | units on a scale | |
| Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Pregabalin | 29.3 | Standard Deviation 23.3 | units on a scale | |
| Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Placebo | 43.6 | Standard Deviation 29.0 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 41 | |
| Overall Study | STARTED | Placebo | 44 | |
| Overall Study | COMPLETED | Pregabalin | 32 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Pregabalin | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events118
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Insomnia | General disorders | Pregabalin | 1 | 41 | 1 |
| other | Insomnia | General disorders | Placebo | 1 | 44 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Pregabalin | 6 | 41 | 7 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 7 | 44 | 11 |
| other | Tired | General disorders | Pregabalin | 6 | 41 | 9 |
| other | Tired | General disorders | Placebo | 5 | 44 | 5 |
| other | Pain in lower chest | Musculoskeletal and connective tissue disorders | Pregabalin | 4 | 41 | 4 |
| other | Pain in lower chest | Musculoskeletal and connective tissue disorders | Placebo | 0 | 44 | 0 |
| other | Cramping right side | Musculoskeletal and connective tissue disorders | Pregabalin | 1 | 41 | 1 |
| other | Cramping right side | Musculoskeletal and connective tissue disorders | Placebo | 0 | 44 | 0 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 28 | 41 |
| Total, other adverse events | Placebo | 24 | 44 |
| Total, serious adverse events | Pregabalin | 1 | 41 |
| Total, serious adverse events | Placebo | 0 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00977197
GET https://conductscience.org/api/trials/v1/NCT00977197/results?page=2