Trial · NCT00765999
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00765999, Phase 3, Completed, Forest Laboratories; results first posted 2019-02-15
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 NCT00765999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00765999
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
- NCT00765999
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,559 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Chronic Constipation, Irritable Bowel Syndrome With Constipation
- Interventions
- Linaclotide
- First posted
- 2008-10-03
- Last updated
- 2019-02-15
- Results first posted
- 2019-02-15
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 Events (TEAEs) | Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs. | An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs). |
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 Events (TEAEs) | Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs. | The analysis population consisted of participants in the Enrolled Population who received at least 1 dose of the open-label investigational product. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included in both the IBS-C and CC Safety Populations, leading to an analyzed population of 1555. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
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 Events (TEAEs) | Linaclotide (CC) | 399 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Linaclotide (IBS-C) | 748 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Linaclotide | 1,554 | |
| Overall Study | COMPLETED | Linaclotide | 770 | |
| Overall Study | NOT COMPLETED | Linaclotide | 784 |
Source ClinicalTrials.gov
Adverse events198
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 | Linaclotide (CC) | 179 | 523 | |
| other | Diarrhoea | Gastrointestinal disorders | Linaclotide (IBS-C) | 345 | 1,032 | |
| other | Abdominal pain | Gastrointestinal disorders | Linaclotide (CC) | 34 | 523 | |
| other | Abdominal pain | Gastrointestinal disorders | Linaclotide (IBS-C) | 69 | 1,032 | |
| other | Nausea | Gastrointestinal disorders | Linaclotide (CC) | 29 | 523 | |
| other | Nausea | Gastrointestinal disorders | Linaclotide (IBS-C) | 51 | 1,032 | |
| other | Abdominal distension | Gastrointestinal disorders | Linaclotide (CC) | 28 | 523 | |
| other | Abdominal distension | Gastrointestinal disorders | Linaclotide (IBS-C) | 35 | 1,032 | |
| other | Upper respiratory tract infection | Infections and infestations | Linaclotide (CC) | 31 | 523 | |
| other | Upper respiratory tract infection | Infections and infestations | Linaclotide (IBS-C) | 65 | 1,032 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Linaclotide (CC) | ||
| Total, all-cause mortality | Linaclotide (IBS-C) | ||
| Total, other adverse events | Linaclotide (CC) | 267 | 523 |
| Total, other adverse events | Linaclotide (IBS-C) | 510 | 1,032 |
| Total, serious adverse events | Linaclotide (CC) | 31 | 523 |
| Total, serious adverse events | Linaclotide (IBS-C) | 57 | 1,032 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Linaclotide (CC) vs Linaclotide (IBS-C): Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Linaclotide (CC) vs Linaclotide (IBS-C): serious adverse events | 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/NCT00765999
GET https://conductscience.org/api/trials/v1/NCT00765999/events?page=2