Trial · NCT02590432
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
NCT02590432, Phase 4, Completed, Forest Laboratories; results first posted 2019-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation. Trials, record NCT02590432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02590432
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
- NCT number
- NCT02590432
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 828 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Irritable Bowel Syndrome With Constipation, Chronic Idiopathic Constipation
- Interventions
- Linaclotide
- First posted
- 2015-10-29
- Last updated
- 2019-08-22
- Results first posted
- 2019-08-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum | Baseline (Day 1) up to 52 weeks or 8 months post last dose if ADA positive at Week 52 (approximately 84 weeks) | Participants who met either of the following criteria: 1) treatment-induced ADA-positive (≥ 1 postbaseline ADA-positive sample) for baseline ADA negative or ADA-undetermined participants or 2) treatment-boosted ADA-positive (≥ 1 postbaseline ADA-positive sample with titer values ≥ 4-fold the baseline titer value) for baseline ADA-positive participants were reported as a ADA positive responder. |
| Secondary | Change From Baseline in Participant's Assessment of Constipation Severity | Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Participants rated constipation severity during the previous 7 days on a 5-point ordinal scale where, 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. Higher scores indicate greater severity. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Participant Assessment of Irritable Bowel Syndrome (IBS) Symptom Severity for Participants With Irritable Bowel Syndrome With Constipation (IBS-C) | Baseline (Day 1) to Week 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Participants rated IBS symptoms severity during the previous 7 days on a 5-point ordinal scale where, 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very severe. Higher scores indicate greater severity. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Degree of Relief of IBS Symptoms for Participants With IBS-C | Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Participants rated degree of relief of IBS symptoms during previous 7 days on a 7-point balanced ordinal scale where, 1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse and 7=as bad as I can imagine. Lower scores indicate greater relief. A negative change from Baseline indicates improvement. |
| Secondary | IBS Treatment Satisfaction Assessment Postbaseline for Participants With IBS-C | Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Participants rated degree of satisfaction with the LINZESS®'s ability to relieve IBS symptoms on a 5-point ordinal scale where, 1=Not at all satisfied, 2=A little satisfied, 3=Moderately satisfied, 4=Quite satisfied and 5=Very satisfied. Higher scores indicate greater satisfaction. |
| Secondary | Constipation Treatment Satisfaction Assessment Postbaseline for Participants With Chronic Idiopathic Constipation (CIC) | Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Participants rated degree of satisfaction with LINZESS®'s ability to relieve constipation symptoms on a 5-point ordinal scale where 1=Not at all satisfied, 2=A little satisfied, 3=Moderately satisfied, 4=Quite satisfied and 5=Very satisfied. Higher scores indicate greater satisfaction. |
| Secondary | Number of Participants With Recurrence of Diarrhea | From first dose in the Double-blind Treatment Period to Week 52 | Participant reporting any instance of diarrhea during the Double-blind Treatment Period. |
| Secondary | Number of Participants With Recurrence of Intolerable Diarrhea | From first dose in the Double-blind Treatment Period to Week 52 | Participants reporting any instance of intolerable diarrhea during the Double-blind Treatment Period (Non-responder otherwise). Only includes participants reporting intolerable diarrhea during the Open-label Treatment Period. |
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAE) | From first dose of study treatment up to Week 52 | An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. |
| Secondary | Time to First Recurrence of Diarrhea | From first dose in the Double-blind Treatment Period to Week 52 | Time to first recurrence of diarrhea was defined as event/censored date - double-blind start date + 1, where event date (responders) = first recurrence of diarrhea date during the double-blind treatment period; censoring date (non-responders) = double-blind end date. Only includes participants reporting intolerable diarrhea during the open-label treatment period. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum | Baseline (Day 1) up to 52 weeks or 8 months post last dose if ADA positive at Week 52 (approximately 84 weeks) | Safety population included all participants in the screened population (all participants who had signed an informed consent form (ICF) for the study and received a patient identification number) who received ≥ 1 administration of study treatment. Participants with ≥ 1 assessable postbaseline sample were analyzed (ADA-undetermined excluded). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Participant's Assessment of Constipation Severity | Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Intent to Treat (ITT) population included all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed were the participants with analysis values at both baseline and postbaseline during the specified time period. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Participant Assessment of Irritable Bowel Syndrome (IBS) Symptom Severity for Participants With Irritable Bowel Syndrome With Constipation (IBS-C) | Baseline (Day 1) to Week 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | ITT population consisted of all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed were the participants with analysis values at both baseline and postbaseline during the specified time period. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Degree of Relief of IBS Symptoms for Participants With IBS-C | Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | Intent-to-treat (ITT) population included all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed were the participants with analysis values at both baseline and postbaseline during the specified time period. | score on a scale | MEAN |
| SECONDARY | IBS Treatment Satisfaction Assessment Postbaseline for Participants With IBS-C | Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | ITT population included all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Constipation Treatment Satisfaction Assessment Postbaseline for Participants With Chronic Idiopathic Constipation (CIC) | Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period) | ITT population consisted of all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Recurrence of Diarrhea | From first dose in the Double-blind Treatment Period to Week 52 | Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrence of Intolerable Diarrhea | From first dose in the Double-blind Treatment Period to Week 52 | Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAE) | From first dose of study treatment up to Week 52 | Safety population included all participants in the screened population who received ≥ 1 administration of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Time to First Recurrence of Diarrhea | From first dose in the Double-blind Treatment Period to Week 52 | Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period. | days | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group64
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 Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum | LINZESS® 145 μg (CIC, Open Label) | 3 | Participants | ||
| Number of Participants With Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum | LINZESS® 290 μg (IBS-C, Open Label) | 1 | Participants | ||
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 145 μg (CIC, Open Label) | Baseline | 3.5 | Standard Deviation 0.8 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 290 μg (IBS-C, Open Label) | Baseline | 3.4 | Standard Deviation 0.8 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 145 μg (CIC, Open Label) | Change from Baseline at Week 2 | -1.1 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 290 μg (IBS-C, Open Label) | Change from Baseline at Week 2 | -1.2 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 145 μg (CIC, Open Label) | Change from Baseline at Week 4 | -1.3 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 290 μg (IBS-C, Open Label) | Change from Baseline at Week 4 | -1.3 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 145 μg (CIC, Open Label) | Change from Baseline at Week 12 | -1.4 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Participant's Assessment of Constipation Severity | LINZESS® 290 μg (IBS-C, Open Label) | Change from Baseline at Week 12 | -1.3 | Standard Deviation 1.2 | score on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Treatment Period | STARTED | LINZESS® 145 μg (CIC, Open Label) | 508 | |
| Open-label Treatment Period | STARTED | LINZESS® 290 μg (IBS-C, Open Label) | 318 | |
| Open-label Treatment Period | STARTED | LINZESS® 290 μg (IBS-C, Double Blind) | 0 | |
| Open-label Treatment Period | STARTED | LINZESS® 145 μg (IBS-C, Double Blind) | 0 | |
| Open-label Treatment Period | STARTED | LINZESS® 72 μg (IBS-C, Double Blind) | 0 | |
| Open-label Treatment Period | STARTED | LINZESS® 145 μg (CIC, Double Blind) | 0 | |
| Open-label Treatment Period | STARTED | LINZESS® 72 μg (CIC, Double Blind) | 0 | |
| Open-label Treatment Period | STARTED | LINZESS® 72 μg (CIC, Dose-reduced Open Label) | 0 | |
| Open-label Treatment Period | STARTED | LINZESS® 72 μg (IBS-C, Dose-reduced Open Label) | 0 | |
| Open-label Treatment Period | COMPLETED | LINZESS® 145 μg (CIC, Open Label) | 276 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events84
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 | LINZESS® 145 μg (CIC) | 130 | 508 | |
| other | Diarrhoea | Gastrointestinal disorders | LINZESS® 290 μg (IBS-C) | 116 | 318 | |
| other | Flatulence | Gastrointestinal disorders | LINZESS® 145 μg (CIC) | 11 | 508 | |
| other | Flatulence | Gastrointestinal disorders | LINZESS® 290 μg (IBS-C) | 18 | 318 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | LINZESS® 145 μg (CIC) | 0 | 508 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | LINZESS® 290 μg (IBS-C) | 1 | 318 | |
| serious | Angina pectoris | Cardiac disorders | LINZESS® 145 μg (CIC) | 2 | 508 | |
| serious | Angina pectoris | Cardiac disorders | LINZESS® 290 μg (IBS-C) | 0 | 318 | |
| serious | Thyroid mass | Endocrine disorders | LINZESS® 145 μg (CIC) | 0 | 508 | |
| serious | Thyroid mass | Endocrine disorders | LINZESS® 290 μg (IBS-C) | 1 | 318 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LINZESS® 145 μg (CIC) | 1 | 508 |
| Total, all-cause mortality | LINZESS® 290 μg (IBS-C) | 0 | 318 |
| Total, other adverse events | LINZESS® 145 μg (CIC) | 133 | 508 |
| Total, other adverse events | LINZESS® 290 μg (IBS-C) | 122 | 318 |
| Total, serious adverse events | LINZESS® 145 μg (CIC) | 16 | 508 |
| Total, serious adverse events | LINZESS® 290 μg (IBS-C) | 6 | 318 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LINZESS® 145 μg (CIC, Open Label) vs LINZESS® 290 μg (IBS-C, Open Label): Number of Participants With Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum | Trial comparisons |
| LINZESS® 145 μg (CIC) vs LINZESS® 290 μg (IBS-C): deaths from any cause | Trial comparisons |
| LINZESS® 145 μg (CIC) vs LINZESS® 290 μg (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/NCT02590432
GET https://conductscience.org/api/trials/v1/NCT02590432/results?page=2