Chronic Idiopathic ConstipationPhase 3NCT02291679

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

A Phase 3 study testing Linaclotide in people with Chronic Idiopathic Constipation, run by Ironwood Pharmaceuticals, Inc. at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Idiopathic Constipation
What is being tested?: Linaclotide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,223 participants
Where: 95 sitesUnited States
Study dates: Oct 2014to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
Patient is compliant with daily interactive voice response system (IVRS) calls
Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

Who cannot join

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.

Trial locations and contacts

95 sites in 1 country.

City, postcode or hospital

95 sites in 1 country

United States95 sites

Ironwood Investigational Site
Anaheim, California, 92801
Ironwood Investigational Site
Anderson, South Carolina, 29621
Ironwood Investigational Site
Atlanta, Georgia, 30328
Ironwood Investigational Site
Baltimore, Maryland, 21215
Ironwood Investigational Site
Bastrop, Louisiana, 71220
Ironwood Investigational Site
Beaumont, Texas, 77701
Ironwood Investigational Site
Boston, Massachusetts, 02135
Ironwood Investigational Site
Boynton Beach, Florida, 33426
Ironwood Investigational Site
Bozeman, Montana, 59718
Ironwood Investigational Site
Bristol, Connecticut, 06010
Ironwood Investigational Site
Bristol, Tennessee, 37620
Ironwood Investigational Site
Brooklyn, New York, 11206
Ironwood Investigational Site
Charlotte, North Carolina, 28209
Ironwood Investigational Site
Charlotte, North Carolina, 28226
Ironwood Investigational Site
Chattanooga, Tennessee, 37421
Ironwood Investigational Site
Chesterfield, Michigan, 48047
Ironwood Investigational Site
Chevy Chase, Maryland, 20815
Ironwood Investigational Site
Christiansburg, Virginia, 24073
Ironwood Investigational Site
Chula Vista, California, 91910
Ironwood Investigational Site
Cincinnati, Ohio, 45219
Ironwood Investigational Site
Cincinnati, Ohio, 45224
Ironwood Investigational Site
Colorado Springs, Colorado, 80904
Ironwood Investigational Site
Columbus, Ohio, 43214
Ironwood Investigational Site
Coral Gables, Florida, 33134
Ironwood Investigational Site
Dakota Dunes, South Dakota, 57049
Ironwood Investigational Site
Dallas, Texas, 75230
Ironwood Investigational Site
DeLand, Florida, 32720
Ironwood Investigational Site
El Paso, Texas, 79905
Ironwood Investigational Site
Endwell, New York, 13760
Ironwood Investigational Site
Evansville, Indiana, 47714
Ironwood Investigational Site
Fargo, North Dakota, 58103
Ironwood Investigational Site
Garden Grove, California, 92843
Ironwood Investigational Site
Great Neck, New York, 11023
Ironwood Investigational Site
Greensboro, North Carolina, 27403
Ironwood Investigational Site
Greer, South Carolina, 29651
Ironwood Investigational Site
Hagerstown, Maryland, 21740
Ironwood Investigational Site
Hialeah, Florida, 33016
Ironwood Investigational Site
High Point, North Carolina, 27262
Ironwood Investigational Site
Hollywood, Maryland, 20636
Ironwood Investigational Site
Houston, Texas, 77074
Ironwood Investigational Site
Houston, Texas, 77098
Ironwood Investigational Site
Huntsville, Alabama, 35801
Ironwood Investigational Site
Inverness, Florida, 34452
Ironwood Investigational Site
Jackson, Mississippi, 39202
Ironwood Investigational Site
Jupiter, Florida, 33458
Ironwood Investigational Site
Kissimmee, Florida, 34741
Ironwood Investigational Site
Knoxville, Tennessee, 37919
Ironwood Investigational Site
La Crosse, Wisconsin, 54601
Ironwood Investigational Site
La Mesa, California, 91942
Ironwood Investigational Site
Las Vegas, Nevada, 89119
Ironwood Investigational Site
Las Vegas, Nevada, 89121
Ironwood Investigational Site
Lauderdale Lakes, Florida, 33319
Ironwood Investigational Site
Lenoir, North Carolina, 28645
Ironwood Investigational Site
Levittown, Pennsylvania, 19056
Ironwood Investigational Site
Longview, Texas, 75605
Ironwood Investigational Site
Lynchburg, Virginia, 24502
Ironwood Investigational Site
Mentor, Ohio, 44060
Ironwood Investigational Site
Metairie, Louisiana, 70006
Ironwood Investigational Site
Miami, Florida, 33015
Ironwood Investigational Site
Miami, Florida, 33126
Ironwood Investigational Site
Miami, Florida, 33133
Ironwood Investigational Site
Miami, Florida, 33135
Ironwood Investigational Site
Miami, Florida, 33165
Ironwood Investigational Site
Miami, Florida, 33175
Ironwood Investigational Site
North Hollywood, California, 91606
Ironwood Investigational Site
North Little Rock, Arkansas, 72117
Ironwood Investigational Site
Oakwood, Georgia, 30566
Ironwood Investigational Site
Oklahoma City, Oklahoma, 73112
Ironwood Investigational Site
Orange, California, 92868
Ironwood Investigational Site
Orlando, Florida, 32806
Ironwood Investigational Site
Ormond Beach, Florida, 32174
Ironwood Investigational Site
Phoenix, Arizona, 85018
Ironwood Investigational Site
Port Orange County, Florida, 32129
Ironwood Investigational Site
Raleigh, North Carolina, 27612
Ironwood Investigational Site
San Antonio, Texas, 78209
Ironwood Investigational Site
San Antonio, Texas, 78229
Ironwood Investigational Site
San Antonio, Texas, 78258
Ironwood Investigational Site
San Diego, California, 92108
Ironwood Investigational Site
Sandy Springs, Georgia, 30328
Ironwood Investigational Site
Shreveport, Louisiana, 71103
Ironwood Investigational Site
Simpsonville, South Carolina, 29681
Ironwood Investigational Site
South Miami, Florida, 33143
Ironwood Investigational Site
South Ogden, Utah, 84405
Ironwood Investigational Site
St Louis, Missouri, 63128
Ironwood Investigational Site
Sylvania, Ohio, 43560
Ironwood Investigational Site
Tampa, Florida, 33634
Ironwood Investigational Site
Thousand Oaks, California, 91360
Ironwood Investigational Site
Troy, Michigan, 48098
Ironwood Investigational Site
Tucson, Arizona, 85712
Ironwood Investigational Site
Wellesley, Massachusetts, 02481
Ironwood Investigational Site
West Palm Beach, Florida, 33409
Ironwood Investigational Site
Wilmington, North Carolina, 28401
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103
Ironwood Investigational Site
Winter Park, Florida, 32792
Ironwood Investigational Site
Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation

Read the detailed description

The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.

Conditions: Chronic Idiopathic Constipation
Being tested: Linaclotide, Matching Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LinaclotideDrug
Also called Linzess, Constella
Matching PlaceboDrug

Study groups in NCT02291679
Study group	Role	What they receive
72 μg linaclotide	Experimental	72 μg oral linaclotide, once daily for 12 weeks Receives: Drug: Linaclotide
145 μg linaclotide	Experimental	145 μg oral linaclotide, once daily for 12 weeks Receives: Drug: Linaclotide
Placebo	Placebo comparator	matching placebo, once daily for 12 weeks Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of 12-Week CSBM Overall Responders
A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is 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.
Measured: Week 12

Secondary outcomes (10)

Change From Baseline in 12-Week CSBM Frequency Rate
A participant's 12-week CSBM Frequency Rate is the CSBM rate (CSBMs/week) calculated over the 12 weeks of the Treatment Period. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a 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.
Measured: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week SBM Frequency Rate
A participant's 12-week SBM Frequency Rate is the SBM rate (SBMs/week) calculated over the 12-weeks of the Treatment Period. An SBM is defined as a 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.
Measured: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week Stool Consistency Score
Stool consistency was measured daily using the 7-point ordinal Bristol Stool Form Scale (BSFS; 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]). The participant's BSFS score for the Treatment Period is the average of the non-missing BSFS scores from the SBMs reported by the participant during the 12-week Treatment Period.
Measured: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week Straining Score
Straining was measured daily using a 5-point ordinal scale (1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = a great deal; 5 = an extreme amount). The participant's straining score for the Treatment Period is the average of the non-missing straining scores from the SBMs reported by the participant during the 12-week Treatment Period.
Measured: Baseline, Week 1 to Week 12
Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)
A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥4 IVRS calls for the specified week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a 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.
Measured: Week 12
Percentage of Month 1 CSBM Responders
A Month 1 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 1 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a 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.
Measured: Month 1
Percentage of Month 2 CSBM Responders
A Month 2 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 2 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a 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.
Measured: Month 2
Percentage of Month 3 CSBM Responders
A Month 3 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 3 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a 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.
Measured: Month 3
Change From Baseline in 12-Week Abdominal Bloating
Abdominal bloating was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal bloating score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal bloating scores reported during the 12-week Treatment Period.
Measured: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week Abdominal Discomfort
Abdominal discomfort was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal discomfort score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal discomfort scores reported during the 12-week Treatment Period.
Measured: Baseline, Week 1 to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Aug 2015

First posted14 Nov 2014 (estimated)
Study startOct 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02291679
Sponsor's protocol ID: MCP-103-309
Status last verified: May 2017
First submitted: 11 Nov 2014
Last updated: 15 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)

All Chronic Idiopathic Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
ClinicalTrials.gov ID: NCT02291679
Acronym / sponsor ID: MCP-103-309
Conditions: Chronic Idiopathic Constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,223 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Forest Laboratories
Study start: Oct 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 14 Nov 2014 (estimated)
Results: Posted 19 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
72 μg linaclotide	Experimental	Drug: Linaclotide72 μg oral linaclotide, once daily for 12 weeks
145 μg linaclotide	Experimental	Drug: Linaclotide145 μg oral linaclotide, once daily for 12 weeks
Placebo	Placebo comparator	Drug: Matching Placebomatching placebo, once daily for 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
Patient is compliant with daily interactive voice response system (IVRS) calls
Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

Key exclusion criteria (5 listed)

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LinaclotideAlso: Linzess, Constella	Drug	145 μg linaclotide, 72 μg linaclotide
Matching Placebo	Drug	Placebo

Primary outcome

Percentage of 12-Week CSBM Overall Responders
Time frame: Week 12
A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is 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.

10 secondary outcomes

Change From Baseline in 12-Week CSBM Frequency Rate
Time frame: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week SBM Frequency Rate
Time frame: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week Stool Consistency Score
Time frame: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week Straining Score
Time frame: Baseline, Week 1 to Week 12
Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)
Time frame: Week 12
Percentage of Month 1 CSBM Responders
Time frame: Month 1
Percentage of Month 2 CSBM Responders
Time frame: Month 2
Percentage of Month 3 CSBM Responders
Time frame: Month 3
Change From Baseline in 12-Week Abdominal Bloating
Time frame: Baseline, Week 1 to Week 12
Change From Baseline in 12-Week Abdominal Discomfort
Time frame: Baseline, Week 1 to Week 12

Results and safety

Results posted to the registry on 19 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	401	357
72 μg Linaclotide	411	369
145 μg Linaclotide	411	352

Primary outcome: Percentage of 12-Week CSBM Overall Responders

Time frame: Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 401	72 μg Linaclotide n = 411
Responder	4.7	13.4
Non-Responder	95.3	86.6

Placebo vs 72 μg Linaclotide: Odds Ratio (OR): 3.03 (95% CI 1.76 to 5.20), p < 0.0001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a primary endpoint; per protocol, data for the 145 μg dose arm were not collected for any pre-specified primary or secondary outcome measures.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of double-blind study drug up to Week 12/End of Treatment Visit (Day 85 + 3 days) for nonserious events and within 30 days of the date of last dose of double-blind study drug for serious events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 401 (1%)	28 of 401 (7%)	Not reported
72 μg Linaclotide	3 of 411 (0.7%)	79 of 411 (19.2%)	Not reported
145 μg Linaclotide	2 of 411 (0.5%)	91 of 411 (22.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Idiopathic Constipation

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard J Lavins, MD study chair

Ironwood Pharmaceuticals, Inc.

95 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide in people with Chronic Idiopathic Constipation, run by Ironwood Pharmaceuticals, Inc. at 95 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of 12-Week CSBM Overall Responders (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02291679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.