Trial · NCT00730171
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00730171, Phase 3, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2018-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation. Trials, record NCT00730171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
- NCT number
- NCT00730171
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,743 participants, actual
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Conditions
- Irritable Bowel Syndrome With Constipation, Chronic Constipation
- Interventions
- Linaclotide
- First posted
- 2008-08-08
- Last updated
- 2018-02-19
- Results first posted
- 2018-02-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose of open-label study drug up to 78 weeks | For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose of open-label study drug up to 78 weeks | Enrolled participants who received at least 1 dose of open-label study drug. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included as an RI participant in the CC Safety Population, and as an RO participant in both the IBS-C and Overall Safety Populations. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | CC Safety Population: Total | 65 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | IBS-C Safety Population: Total | 389 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Overall Safety Population: Total | 454 | Participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overal Safey Population: Total | 1,725 | |
| Overall Study | CC Safety Population | Overal Safey Population: Total | 607 | |
| Overall Study | IBS-C Safety Population | Overal Safey Population: Total | 1,119 | |
| Overall Study | COMPLETED | Overal Safey Population: Total | 954 | |
| Overall Study | NOT COMPLETED | Overal Safey Population: Total | 771 |
Source ClinicalTrials.gov
Adverse events309
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 | Diarrhoea | Gastrointestinal disorders | CC Safety Population: Total | 179 | 607 | |
| other | Diarrhoea | Gastrointestinal disorders | IBS-C Safety Population: Total | 358 | 1,119 | |
| other | Diarrhoea | Gastrointestinal disorders | Overall Safety Population: Total | 537 | 1,725 | |
| other | Abdominal pain | Gastrointestinal disorders | CC Safety Population: Total | 23 | 607 | |
| other | Abdominal pain | Gastrointestinal disorders | IBS-C Safety Population: Total | 74 | 1,119 | |
| other | Abdominal pain | Gastrointestinal disorders | Overall Safety Population: Total | 97 | 1,725 | |
| other | Nausea | Gastrointestinal disorders | CC Safety Population: Total | 36 | 607 | |
| other | Nausea | Gastrointestinal disorders | IBS-C Safety Population: Total | 59 | 1,119 | |
| other | Nausea | Gastrointestinal disorders | Overall Safety Population: Total | 95 | 1,725 | |
| other | Constipation | Gastrointestinal disorders | CC Safety Population: Total | 16 | 607 |
1 to 10 of 309Source ClinicalTrials.gov
See all 309 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CC Safety Population: Total | 2 | 607 |
| Total, all-cause mortality | IBS-C Safety Population: Total | 2 | 1,119 |
| Total, all-cause mortality | Overall Safety Population: Total | 4 | 1,725 |
| Total, other adverse events | CC Safety Population: Total | 283 | 607 |
| Total, other adverse events | IBS-C Safety Population: Total | 572 | 1,119 |
| Total, other adverse events | Overall Safety Population: Total | 855 | 1,725 |
| Total, serious adverse events | CC Safety Population: Total | 41 | 607 |
| Total, serious adverse events | IBS-C Safety Population: Total | 56 | 1,119 |
| Total, serious adverse events | Overall Safety Population: Total | 97 | 1,725 |
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/NCT00730171
GET https://conductscience.org/api/trials/v1/NCT00730171/events?page=2