Irritable Bowel Syndrome With Constipation (IBS-C)Phase 3D5630C00001NCT01880424

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3 study testing Linaclotide in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by AstraZeneca at 82 sites in 5 countries.

Completed

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

Official record

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Trial summary

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome With Constipation (IBS-C)
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: 1,722 participants
Where: 82 sitesin 5 countries
Study dates: Jul 2013to May 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 signed an Informed Consent Form(ICF).
Patient Must not be pregnant or breastfeeding and agree to use birth control
Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms

Who cannot join

Recent history of mushy or watery stools
Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
Surgery to the gastrointestinal tract
Usage of prohibited medications

Trial locations and contacts

82 sites in 5 countries.

Country

City, postcode or hospital

82 sites in 5 countries

United States52 sites

Research Site
Addison, Illinois
Research Site
Artesia, California
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Billings, Montana
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Boston, Massachusetts
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Boynton Beach, Florida
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Brandon, Florida
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Brooklyn, New York
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Brooksville, Florida
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Chattanooga, Tennessee
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Chesterfield, Michigan
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Chula Vista, California
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Cincinnati, Ohio
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Crowley, Louisiana
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Dayton, Ohio
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Doral, Florida
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Encino, California
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Evansville, Indiana
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Franklin, Ohio
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Gainesville, Florida
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Great Neck, New York
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Greer, South Carolina
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Hialeah, Florida
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Houston, Texas
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Huntsville, Alabama
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Kingsport, Tennessee
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Kissimmee, Florida
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Knoxville, Tennessee
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Las Vegas, Nevada
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Lauderdale Lakes, Florida
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Lynchburg, Virginia
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Mentor, Ohio
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Miami, Florida
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Miami Lakes, Florida
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Monroe, Louisiana
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Morgantown, West Virginia
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New York, New York
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North Hollywood, California
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North Little Rock, Arkansas
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Ogden, Utah
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Orange, California
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Phoenix, Arkansas
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Raleigh, North Carolina
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Riverside, California
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Salisbury, North Carolina
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San Antonio, Texas
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San Diego, California
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Shreveport, Louisiana
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Smyrna, Tennessee
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St Louis, Missouri
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Webster, Texas
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Winston-Salem, North Carolina
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Wyoming, Michigan

Other trials in United States

China17 sites

Research Site
Beijing
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Changsha
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Chengdu
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Chongqing
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Guangzhou
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Hangzhou
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Harerbin
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Hefei
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Jinan
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Nanchang
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Qingdao
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Shanghai
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Shenyang
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Shijiazhuang
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Wuhan
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Xi'an
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Xiamen

Other trials in China

Australia7 sites

Research Site
Adelaide
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Brisbane
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Five Dock
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Malvern
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Maroubra
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Melbourne
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Parkville

Other trials in Australia

New Zealand5 sites

Research Site
Auckland
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Christchurch
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Dunedin
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Tauranga
Research Site
Wellington

Other trials in New Zealand

Canada1 site

Research Site
Vaughan, Ontario

Other trials in Canada

About this study

The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Being tested: Placebo, Linaclotide

What participants receive

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

PlaceboDrug
matching Placebo Capsules, Oral, once daily
LinaclotideDrug
Linaclotide 290 ug Capsules, Oral, once daily

Study groups in NCT01880424
Study group	Role	What they receive
controlled arm	Placebo comparator	Not described Receives: Drug: Placebo
treatment arm	Experimental	Not described Receives: Drug: Linaclotide

What is being measured

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

12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period.
Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
Measured: Baseline and Weeks 1-12 during the Treatment Period
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period.
Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
Measured: Baseline and Weeks 1-12 during the Treatment Period

Secondary outcomes (7)

Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period).
A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation.
Measured: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period).
SBM is defined as a bowel movement without laxative use in the preceding 24 hours.
Measured: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Stool Consistency
The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period).
Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid]).
Measured: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Severity of Straining
The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period).
Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount).
Measured: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Bloating
The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period).
Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
Measured: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Pain
The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period).
Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Measured: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Discomfort
The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period).
Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
Measured: Baseline and 12-week Treatment Period

Timeline

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

Jul 2013May 2015

First posted19 Jun 2013 (estimated)
Study startJul 2013
Primary completionMay 2015
Study completionMay 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel Syndrome With Constipation (IBS-C)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,722 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01880424
Sponsor's protocol ID: ICP-103-307
Acronym: D5630C00001
Status last verified: Aug 2016
First submitted: 12 Jun 2013
Last updated: 27 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Peng LH, Fang JY, Dai N, Shen XZ, Yang YL, Sun J, Yang YS. Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial. J Dig Dis. 2022 Feb;23(2):99-110. doi: 10.1111/1751-2980.13081.
PubMed 35019221

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

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation
Not yet recruiting
Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
Irritable Bowel Syndrome (IBS-C)
Enrolling by invitationPhase 3
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
Irritable Bowel Syndrome With Constipation (IBS-C)
Not yet recruitingObservational study
Soluble and Osmotic Fibre (SOLOS) Diet for Constipation
Constipation, Constipation - Functional

All Irritable Bowel Syndrome With Constipation (IBS-C) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
ClinicalTrials.gov ID: NCT01880424
Acronym / sponsor ID: D5630C00001 / ICP-103-307
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,722 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Ironwood Pharmaceuticals, Inc.
Study start: Jul 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 19 Jun 2013 (estimated)
Results: Posted 27 Sep 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
controlled arm	Placebo comparator	Drug: Placebo
treatment arm	Experimental	Drug: Linaclotide

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 signed an Informed Consent Form(ICF).
Patient Must not be pregnant or breastfeeding and agree to use birth control
Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms

Key exclusion criteria (5 listed)

Recent history of mushy or watery stools
Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
Surgery to the gastrointestinal tract
Usage of prohibited medications

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
Placebomatching Placebo Capsules, Oral, once daily	Drug	controlled arm
LinaclotideLinaclotide 290 ug Capsules, Oral, once daily	Drug	treatment arm

Primary outcome

12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
Time frame: Baseline and Weeks 1-12 during the Treatment Period
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
Time frame: Baseline and Weeks 1-12 during the Treatment Period
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.

7 secondary outcomes

Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Stool Consistency
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Severity of Straining
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Bloating
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Pain
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Discomfort
Time frame: Baseline and 12-week Treatment Period

Results and safety

Results posted to the registry on 27 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Linaclotide Arm	417	384
Placebo Arm	422	367

Primary outcome: 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder

Time frame: Baseline and Weeks 1-12 during the Treatment Period. Number. Unit: Participants

Measure	Linaclotide Arm n = 417	Placebo Arm n = 422
Value	250	206

Linaclotide Arm vs Placebo Arm: Odds Ratio (OR): 1.59 (95% CI 1.21 to 2.09), p = 0.0010, Cochran-Mantel-Haenszel

Population analysed: Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an abdominal pain score or abdominal discomfort score for a particular Treatment Period week, the patient was not considered a responder for that week.

Primary outcome: 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder

Time frame: Baseline and Weeks 1-12 during the Treatment Period. Number. Unit: Participants

Measure	Linaclotide Arm n = 417	Placebo Arm n = 422
Value	132	65

Linaclotide Arm vs Placebo Arm: Odds Ratio (OR): 2.56 (95% CI 1.83 to 3.58), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an IBS degree of relief score for a particular Treatment Period week, the patient was not considered a responder for that week.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from July 2013 to May 2015 (12 weeks of safety data were collected). Includes serious adverse events that occurred on or after the date of the first dose of study drug and within 30 days of the last dose of study drug.. Other adverse events reported at 0.03% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linaclotide Arm	4 of 416 (1%)	56 of 416 (13.5%)	Not reported
Placebo Arm	10 of 419 (2.4%)	26 of 419 (6.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35019221Peng LH, Fang JY, Dai N, Shen XZ, Yang YL, Sun J, Yang YS. Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial. J Dig Dis. 2022 Feb;23(2):99-110. doi: 10.1111/1751-2980.13081.

Related trials for Irritable Bowel Syndrome With Constipation (IBS-C)

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation
Not yet recruiting
Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
Irritable Bowel Syndrome (IBS-C)
Enrolling by invitationPhase 3
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
Irritable Bowel Syndrome With Constipation (IBS-C)
Not yet recruitingObservational study
Soluble and Osmotic Fibre (SOLOS) Diet for Constipation
Constipation, Constipation - Functional

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.

Yunsheng Yang principal investigator

Chinese PLA General Hospital

Shutian Zhang principal investigator

Beijing Friendship Hospital

Zhaoshen Li principal investigator

Changhai Hospital Affiliated to Second Military Mecical University of Chinese PLA

82 sites in 5 countries: 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 Irritable Bowel Syndrome With Constipation (IBS-C), run by AstraZeneca at 82 sites in 5 countries.

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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, China, Australia, New Zealand, Canada. 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 27 Sep 2016). 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?

12-week Abdominal Pain/Abdominal Discomfort Weekly Responder (time frame: Baseline and Weeks 1-12 during the Treatment Period). The study lists 2 primary outcomes in all. 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 NCT01880424, which also lists 1 linked publication.

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 27 Sep 2016.