Trial · NCT00765882
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
NCT00765882, Phase 3, Completed, Forest Laboratories; results first posted 2013-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation. Trials, record NCT00765882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00765882
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
- NCT number
- NCT00765882
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 633 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Chronic Constipation
- Interventions
- Linaclotide 290 micrograms, Linaclotide 145 micrograms, Placebo
- First posted
- 2008-10-03
- Last updated
- 2013-01-30
- Results first posted
- 2013-01-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Change from Baseline to Week 12 | A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Change from Baseline to Week 12 | The number of CSBMs per week. |
| Secondary | 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate | Change from Baseline to Week 12 | A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period. |
| Secondary | 12-Week Stool Consistency | Change from Baseline to Week 12 | The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale: 1. = separate hard lumps like nuts \[difficult to pass\] 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges \[passed easily\] 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces \[entirely liquid\] |
| Secondary | 12-Week Severity of Straining | Change from Baseline to Week 12 | Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount. |
| Secondary | 12-Week Abdominal Discomfort | Change from Baseline to Week 12 | Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe." |
| Secondary | 12-Week Bloating | Change from Baseline to Week 12 | Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe". |
| Secondary | 12-Week Constipation Severity | Change from Baseline to Week 12 | Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe". |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied. | participants | NUMBER |
| SECONDARY | 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied. | CSBM per week | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied. | SBM per week | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Stool Consistency | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Severity of Straining | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 Patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Abdominal Discomfort | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. 1 additional patient without a baseline Abdominal Discomfort score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Bloating | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 1 additional patient without a baseline Bloating score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Constipation Severity | Change from Baseline to Week 12 | A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 11 additional patients who dropped out prior to finishing 1 week of the trial were excluded from the Constipation Severity endpoint. An observed-cases approach to missing postbaseline data was applied. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Placebo | Responder | 13 | participants | |
| Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Linaclotide 145µg | Responder | 34 | participants | |
| Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Linaclotide 290µg | Responder | 43 | participants | |
| Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Placebo | Nonresponder | 202 | participants | |
| Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Linaclotide 145µg | Nonresponder | 179 | participants | |
| Complete Spontaneous Bowel Movement (CSBM) Overall Responder | Linaclotide 290µg | Nonresponder | 159 | participants | |
| 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Placebo | 0.614 | Standard Error 0.209 | CSBM per week | |
| 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Linaclotide 145µg | 2.011 | Standard Error 0.215 | CSBM per week | |
| 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Linaclotide 290µg | 2.653 | Standard Error 0.217 | CSBM per week | |
| 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate | Placebo | 1.113 | Standard Error 0.265 | SBM per week |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 215 | |
| Overall Study | STARTED | Linaclotide 145µg | 213 | |
| Overall Study | STARTED | Linaclotide 290µg | 205 | |
| Overall Study | COMPLETED | Placebo | 191 | |
| Overall Study | COMPLETED | Linaclotide 145µg | 173 | |
| Overall Study | COMPLETED | Linaclotide 290µg | 169 | |
| Overall Study | NOT COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Linaclotide 145µg | 40 | |
| Overall Study | NOT COMPLETED | Linaclotide 290µg | 36 |
Source ClinicalTrials.gov
Adverse events57
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 | Diarrhea | Gastrointestinal disorders | Placebo | 6 | 215 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide 145µg | 42 | 213 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide 290µg | 30 | 205 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 13 | 215 | |
| other | Flatulence | Gastrointestinal disorders | Linaclotide 145µg | 16 | 213 | |
| other | Flatulence | Gastrointestinal disorders | Linaclotide 290µg | 13 | 205 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 14 | 215 | |
| other | Upper respiratory tract infection | Infections and infestations | Linaclotide 145µg | 16 | 213 | |
| other | Upper respiratory tract infection | Infections and infestations | Linaclotide 290µg | 9 | 205 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 5 | 215 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Linaclotide 145µg | ||
| Total, all-cause mortality | Linaclotide 290µg | ||
| Total, other adverse events | Placebo | 35 | 215 |
| Total, other adverse events | Linaclotide 145µg | 70 | 213 |
| Total, other adverse events | Linaclotide 290µg | 49 | 205 |
| Total, serious adverse events | Placebo | 4 | 215 |
| Total, serious adverse events | Linaclotide 145µg | 3 | 213 |
| Total, serious adverse events | Linaclotide 290µg | 7 | 205 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00765882
GET https://conductscience.org/api/trials/v1/NCT00765882/results?page=2