Trial · NCT00620061
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
NCT00620061, Phase 3, Completed, Sucampo Pharma Americas, LLC; results first posted 2019-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone. Trials, record NCT00620061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00620061
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
- NCT number
- NCT00620061
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 439 participants, actual
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Conditions
- Opioid-Induced Bowel Dysfunction
- Interventions
- Lubiprostone 24
- First posted
- 2008-02-21
- Last updated
- 2020-01-21
- Results first posted
- 2019-12-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. |
| Primary | Mean Weekly Bowel Movements (BMs) Per Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | A Bowel Movement (BM) is defined as any BM (whether spontaneous or not) |
| Secondary | Number of Participants Classified as Monthly Responders | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder. |
| Secondary | Straining Associated With Spontaneous Bowel Movements by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better. |
| Secondary | Stool Consistency of Spontaneous Bowel Movements by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2. |
| Secondary | Constipation Severity by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. |
| Secondary | Abdominal Bloating by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. |
| Secondary | Abdominal Discomfort by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. |
| Secondary | Bowel Habit Regularity by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1. |
| Secondary | Treatment Effectiveness by Month | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4. |
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 Weekly Spontaneous Bowel Movements (SBMs) Per Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat population with evaluable SBM data during the given month | Weekly SBMs | MEAN |
| PRIMARY | Mean Weekly Bowel Movements (BMs) Per Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat population with evaluable BM data during the given month | Weekly BMs | MEAN |
| SECONDARY | Number of Participants Classified as Monthly Responders | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Straining Associated With Spontaneous Bowel Movements by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable data at the given time point | score on a scale | MEAN |
| SECONDARY | Stool Consistency of Spontaneous Bowel Movements by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable data at the given time point | score on a scale | MEAN |
| SECONDARY | Constipation Severity by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable scores at the given time point | score on a scale | MEAN |
| SECONDARY | Abdominal Bloating by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable data at the given time point | score on a scale | MEAN |
| SECONDARY | Abdominal Discomfort by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable data at the given time point | score on a scale | MEAN |
| SECONDARY | Bowel Habit Regularity by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable data at the given time point | score on a scale | MEAN |
| SECONDARY | Treatment Effectiveness by Month | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Intent-to-treat with evaluable data at the given time point | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Baseline | 1.4 | Standard Deviation 0.98 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 1 | 4.9 | Standard Deviation 2.72 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 2 | 4.9 | Standard Deviation 2.62 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 3 | 5.0 | Standard Deviation 2.76 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 4 | 5.0 | Standard Deviation 2.71 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 5 | 5.0 | Standard Deviation 2.82 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 6 | 5.0 | Standard Deviation 2.86 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 7 | 5.1 | Standard Deviation 2.93 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 8 | 5.3 | Standard Deviation 2.91 | Weekly SBMs |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | All Participants | Month 9 | 5.2 | Standard Deviation 3.19 | Weekly SBMs |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lubiprostone | 439 | |
| Overall Study | COMPLETED | Lubiprostone | 286 | |
| Overall Study | NOT COMPLETED | Lubiprostone | 153 |
Source ClinicalTrials.gov
Adverse events51
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 | All Participants | 39 | 439 | |
| other | Diarrhoea | Gastrointestinal disorders | All Participants | 42 | 439 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | All Participants | 28 | 439 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | All Participants | 23 | 439 | |
| serious | Gastroenteritis | Infections and infestations | All Participants | 2 | 439 | |
| serious | Cellulitis | Infections and infestations | All Participants | 2 | 439 | |
| serious | Pneumonia | Infections and infestations | All Participants | 2 | 439 | |
| serious | Papilloma Viral Infection | Infections and infestations | All Participants | 1 | 439 | |
| serious | Osteomyelitis | Infections and infestations | All Participants | 1 | 439 | |
| serious | Nocardiosis | Infections and infestations | All Participants | 1 | 439 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 1 | 439 |
| Total, other adverse events | All Participants | 100 | 439 |
| Total, serious adverse events | All Participants | 34 | 439 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00620061
GET https://conductscience.org/api/trials/v1/NCT00620061/results?page=2