Trial · NCT00380250
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
NCT00380250, Phase 3, Completed, Sucampo Pharma Americas, LLC; results first posted 2014-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation. Trials, record NCT00380250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00380250
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
- NCT number
- NCT00380250
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 590 participants, actual
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- Lubiprostone, Placebo
- First posted
- 2006-09-25
- Last updated
- 2019-11-15
- Results first posted
- 2014-02-11
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Responder Rate | 12 weeks | Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months |
| Secondary | Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | Change from baseline for month 1 | SBMs are any bowel movement not associated with rescue medication use. |
| Secondary | Month 1 Stool Consistency Change From Baseline | Change from baseline for month 1 | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Secondary | Month 1 Bowel Straining Change From Baseline | Change from baseline for month 1 | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 1 Constipation Severity Change From Baseline | Change from baseline at 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 1 Symptom Relief | Change from baseline for month 1 | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 |
| Secondary | Quality of Life Change From Baseline | Change from baseline at 12 weeks | Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase |
| Secondary | Month 2 Responder Rate | month 2 (28 days) | Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. |
| Secondary | Month 3 Responder Rate | month 3 (28 days) | Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse. |
| Secondary | Month 1 Responder Rate | month 1 (28 days) | Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | Change from baseline for month 1 | ITT with LOCF | SBM/week | MEAN |
| SECONDARY | Month 1 Stool Consistency Change From Baseline | Change from baseline for month 1 | ITT with LOCF | Scale score | MEAN |
| SECONDARY | Month 1 Bowel Straining Change From Baseline | Change from baseline for month 1 | ITT with LOCF | Scale score | MEAN |
| SECONDARY | Month 1 Constipation Severity Change From Baseline | Change from baseline at 28 days | ITT with LOCF | Scale score | MEAN |
| SECONDARY | Month 1 Symptom Relief | Change from baseline for month 1 | ITT with LOCF | Scale score | MEAN |
| SECONDARY | Quality of Life Change From Baseline | Change from baseline at 12 weeks | ITT without LOCF | Scale score | MEAN |
| PRIMARY | Overall Responder Rate | 12 weeks | Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF) | percentage of participants | NUMBER |
| SECONDARY | Month 2 Responder Rate | month 2 (28 days) | ITT without LOCF | percent of participants | NUMBER |
| SECONDARY | Month 3 Responder Rate | month 3 (28 days) | ITT without LOCF | percent of participants | NUMBER |
| SECONDARY | Month 1 Responder Rate | month 1 (28 days) | ITT without LOCF | percent of participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | Lubiprostone Study Period I | 1.54 | Standard Deviation 2.462 | SBM/week | |
| Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | Placebo Study Period I | 1.21 | Standard Deviation 2.286 | SBM/week | |
| Month 1 Stool Consistency Change From Baseline | Lubiprostone Study Period I | -0.51 | Standard Deviation 0.690 | Scale score | |
| Month 1 Stool Consistency Change From Baseline | Placebo Study Period I | -0.33 | Standard Deviation 0.626 | Scale score | |
| Month 1 Bowel Straining Change From Baseline | Lubiprostone Study Period I | -0.53 | Standard Deviation 0.739 | Scale score | |
| Month 1 Bowel Straining Change From Baseline | Placebo Study Period I | -0.36 | Standard Deviation 0.694 | Scale score | |
| Month 1 Constipation Severity Change From Baseline | Lubiprostone Study Period I | -0.41 | Standard Deviation 0.602 | Scale score | |
| Month 1 Constipation Severity Change From Baseline | Placebo Study Period I | -0.29 | Standard Deviation 0.568 | Scale score | |
| Month 1 Symptom Relief | Lubiprostone Study Period I | 0.66 | Standard Deviation 1.212 | Scale score | |
| Month 1 Symptom Relief | Placebo Study Period I | 0.57 | Standard Deviation 1.088 | Scale score |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lubiprostone Study Period I | 396 | |
| Overall Study | STARTED | Placebo Study Period I | 194 | |
| Overall Study | COMPLETED | Lubiprostone Study Period I | 297 | |
| Overall Study | COMPLETED | Placebo Study Period I | 139 | |
| Overall Study | NOT COMPLETED | Lubiprostone Study Period I | 99 | |
| Overall Study | NOT COMPLETED | Placebo Study Period I | 55 |
Source ClinicalTrials.gov
Adverse events26
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 | Nausea | Gastrointestinal disorders | Lubiprostone Study Period I | 47 | 396 | 47 |
| other | Nausea | Gastrointestinal disorders | Placebo Study Period I | 11 | 192 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Lubiprostone Study Period I | 28 | 396 | 28 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Study Period I | 11 | 192 | 11 |
| other | Abdominal Pain | Gastrointestinal disorders | Lubiprostone Study Period I | 22 | 396 | 22 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Study Period I | 12 | 192 | 12 |
| serious | Thyroid gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Lubiprostone Study Period I | 1 | 396 | 1 |
| serious | Thyroid gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo Study Period I | 0 | 192 | 0 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Lubiprostone Study Period I | 1 | 396 | 1 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo Study Period I | 0 | 192 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lubiprostone Study Period I | ||
| Total, all-cause mortality | Placebo Study Period I | ||
| Total, other adverse events | Lubiprostone Study Period I | 75 | |
| Total, other adverse events | Placebo Study Period I | 25 | |
| Total, serious adverse events | Lubiprostone Study Period I | 5 | 396 |
| Total, serious adverse events | Placebo Study Period I | 2 | 192 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19006537 | RESULT |
Source PubMed
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 |
|---|
| Lubiprostone Study Period I vs Placebo Study Period I: 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/NCT00380250
GET https://conductscience.org/api/trials/v1/NCT00380250/registered?page=2