Irritable Bowel Syndrome With ConstipationPhase 3NCT00730171

An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

A Phase 3 study testing Linaclotide in people with Irritable Bowel Syndrome With Constipation and Chronic Constipation, run by Ironwood Pharmaceuticals, Inc. at 116 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 study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome With Constipation, Chronic Constipation
What is being tested?: Linaclotide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,743 participants
Where: 116 sitesUnited States
Study dates: Sep 2008to Mar 2012
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

Patients must have
entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
Sexually active patients of childbearing potential agree to use birth control
Females of childbearing potential must have a negative urine pregnancy test prior to dosing
Lactating females must agree not to breastfeed
Patient must meet protocol criteria for CC or IBS-C

Who cannot join

Patient must not use protocol-defined prohibited medicine
Patient is planning to receive an investigational drug at any time during the study
Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test

Trial locations and contacts

116 sites in 1 country.

City, postcode or hospital

116 sites in 1 country

United States116 sites

Ironwood Investigational Site
Albuquerque, New Mexico, 87108
Ironwood Investigational Site
Anaheim, California, 92801
Ironwood Investigational Site
Anderson, Indiana, 46011
Ironwood Investigational Site
Anderson, South Carolina, 29621
Ironwood Investigational Site
Annapolis, Maryland, 21401
Ironwood Investigational Site
Asheboro, North Carolina, 27203
Ironwood Investigational Site
Asheville, North Carolina, 28801
Ironwood Investigational Site
Baltimore, Maryland, 21215
Ironwood Investigational Site
Baton Rouge, Louisiana, 70809
Ironwood Investigational Site
Beachwood, Ohio, 44122
Ironwood Investigational Site
Beaumont, Texas, 77701
Ironwood Investigational Site
Birmingham, Alabama, 35209
Ironwood Investigational Site
Boynton Beach, Florida, 33426
Ironwood Investigational Site
Bristol, Connecticut, 06010
Ironwood Investigational Site
Bristol, Tennessee, 37620
Ironwood Investigational Site
Cedar Knolls, New Jersey, 07927
Ironwood Investigational Site
Chandler, Arizona, 85224
Ironwood Investigational Site
Chapel Hill, North Carolina, 27599
Ironwood Investigational Site
Charleston, South Carolina, 29414
Ironwood Investigational Site
Charlotte, North Carolina, 28211
Ironwood Investigational Site
Chattanooga, Tennessee, 37421
Ironwood Investigational Site
Chesapeake, Virginia, 23320
Ironwood Investigational Site
Chesterfield, Michigan, 48047
Ironwood Investigational Site
Chula Vista, California, 91910
Ironwood Investigational Site
Cincinnati, Ohio, 45224
Ironwood Investigational Site
Cincinnati, Ohio, 45242
Ironwood Investigational Site
Clive, Iowa, 50325
Ironwood Investigational Site
Colorado Springs, Colorado, 80904
Ironwood Investigational Site
Davenport, Iowa, 52807
Ironwood Investigational Site
Dayton, Ohio, 45440
Ironwood Investigational Site
El Paso, Texas, 79905
Ironwood Investigational Site
Encinitas, California, 92024
Ironwood Investigational Site
Fort Worth, Texas, 76104
Ironwood Investigational Site
Garden Grove, California, 92840
Ironwood Investigational Site
Germantown, Tennessee, 38138
Ironwood Investigational Site
Greensboro, North Carolina, 27408
Ironwood Investigational Site
Harrisburg, North Carolina, 28075
Ironwood Investigational Site
Henderson, Nevada, 89104
Ironwood Investigational Site
Hickory, North Carolina, 28602
Ironwood Investigational Site
Hollywood, Florida, 33021
Ironwood Investigational Site
Hollywood, Maryland, 20636
Ironwood Investigational Site
Houston, Texas, 77024
Ironwood Investigational Site
Huntersville, North Carolina, 28078
Ironwood Investigational Site
Huntsville, Alabama, 35801
Ironwood Investigational Site
Inverness, Florida, 34452
Ironwood Investigational Site
Irving, Texas, 75061
Ironwood Investigational Site
Jackson, Mississippi, 39202
Ironwood Investigational Site
Jacksonville, Florida, 32205
Ironwood Investigational Site
Jacksonville, Florida, 32256
Ironwood Investigational Site
Jacksonville, North Carolina, 28546
Ironwood Investigational Site
Jefferson City, Missouri, 65109
Ironwood Investigational Site
Kingsport, Tennessee, 37660
Ironwood Investigational Site
La Crosse, Wisconsin, 54601
Ironwood Investigational Site
Laguna Hills, California, 92653
Ironwood Investigational Site
Lancaster, Pennsylvania, 17604
Ironwood Investigational Site
Lancaster, Pennsylvania, 19606
Ironwood Investigational Site
Las Vegas, Nevada, 89128
Ironwood Investigational Site
Lauderdale Lakes, Florida, 33319
Ironwood Investigational Site
Laurel, Maryland, 20707
Ironwood Investigational Site
Levittown, Pennsylvania, 19056
Ironwood Investigational Site
Longview, Texas, 75605
Ironwood Investigational Site
Los Angeles, California, 90045
Ironwood Investigational Site
Lynchburg, Virginia, 24502
Ironwood Investigational Site
Marlton, New Jersey, 08053
Ironwood Investigational Site
Mentor, Ohio, 44060
Ironwood Investigational Site
Metairie, Louisiana, 70006
Ironwood Investigational Site
Miami, Florida, 33156
Ironwood Investigational Site
Milwaukee, Wisconsin, 53215
Ironwood Investigational Site
Mineola, New York, 11501
Ironwood Investigational Site
Mission, Kansas, 66202
Ironwood Investigational Site
Monroe, Louisiana, 71201
Ironwood Investigational Site
Nashville, Tennessee, 37203
Ironwood Investigational Site
New Bern, North Carolina, 28562
Ironwood Investigational Site
Newnan, Georgia, 30263
Ironwood Investigational Site
Ocean City, New Jersey, 07712
Ironwood Investigational Site
Ogden, Utah, 84405
Ironwood Investigational Site
Oklahoma City, Oklahoma, 73116
Ironwood Investigational Site
Orange, California, 92868
Ironwood Investigational Site
Overland Park, Kansas, 66215
Ironwood Investigational Site
Peoria, Illinois, 61602
Ironwood Investigational Site
Phoenix, Arizona, 85020
Ironwood Investigational Site
Pinellas Park, Florida, 33782
Ironwood Investigational Site
Pittsburgh, Pennsylvania, 15213
Ironwood Investigational Site
Pittsford, New York, 14534
Ironwood Investigational Site
Plymouth, Minnesota, 55446
Ironwood Investigational Site
Port Orange, Florida, 32129
Ironwood Investigational Site
Sacramento, California, 95830
Ironwood Investigational Site
Salt Lake City, Utah, 84107
Ironwood Investigational Site
San Antonio, Texas, 78229
Ironwood Investigational Site
San Carlos, California, 94070
Ironwood Investigational Site
San Diego, California, 92103
Ironwood Investigational Site
San Diego, California, 92108
Ironwood Investigational Site
San Diego, California, 92123
Ironwood Investigational Site
Sellersville, Pennsylvania, 18960
Ironwood Investigational Site
Sherwood, Arkansas, 72120
Ironwood Investigational Site
Shreveport, Louisiana, 71103
Ironwood Investigational Site
Simpsonville, South Carolina, 29681
Ironwood Investigational Site
Spokane, Washington, 99208
Ironwood Investigational Site
Statesville, North Carolina, 28625
Ironwood Investigational Site
Sugar Land, Texas, 77479
Ironwood Investigational Site
Summerville, North Carolina, 29485
Ironwood Investigational Site
Sylvania, Ohio, 43560
Ironwood Investigational Site
Tampa, Florida, 33607
Ironwood Investigational Site
Topeka, Kansas, 66606
Ironwood Investigational Site
Traverse City, Michigan, 49684
Ironwood Investigational Site
Troy, Michigan, 48098
Ironwood Investigational Site
Tucson, Arizona, 85710
Ironwood Investigational Site
Tucson, Arizona, 85715
Ironwood Investigational Site
Tucson, Arizona, 85741
Ironwood Investigational Site
Tupelo, Mississippi, 38801
Ironwood Investigational Site
Vancouver, Washington, 98664
Ironwood Investigational Site
Wadsworth, Ohio, 44281
Ironwood Investigational Site
Wilmington, North Carolina, 28401
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103
Ironwood Investigational Site
Yukon, Oklahoma, 73099
Ironwood Investigational Site
Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Read the detailed description

Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Conditions: Irritable Bowel Syndrome With Constipation, Chronic Constipation
Being tested: Linaclotide

What participants receive

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

LinaclotideDrug
Also called Linzess
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Study groups in NCT00730171
Study group	Role	What they receive
Linaclotide	Experimental	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator. Receives: Drug: Linaclotide

What is being measured

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

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
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.
Measured: From first dose of open-label study drug up to 78 weeks

Timeline

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

Sep 2008Mar 2012

First posted8 Aug 2008 (estimated)
Study startSep 2008
Primary completionMar 2012
Study completionMar 2012

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 Irritable Bowel Syndrome With 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,743 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730171
Sponsor's protocol ID: MCP-103-305
Status last verified: Jan 2018
First submitted: 5 Aug 2008
Last updated: 19 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes

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
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2/3
Home Transcutaneous Electrical Acustimulation (TEA)
Irritable Bowel Syndrome With Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation

All Irritable Bowel Syndrome With Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
ClinicalTrials.gov ID: NCT00730171
Acronym / sponsor ID: MCP-103-305
Conditions: Irritable Bowel Syndrome With Constipation, Chronic Constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,743 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Forest Laboratories
Study start: Sep 2008
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 19 Feb 2018

Clinical summary

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

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Linaclotide	Experimental	Drug: LinaclotideLinaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.

Who may qualify

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

Key inclusion criteria (7 listed)

Patients must have
Sexually active patients of childbearing potential agree to use birth control
Females of childbearing potential must have a negative urine pregnancy test prior to dosing
Lactating females must agree not to breastfeed
Patient must meet protocol criteria for CC or IBS-C

Key exclusion criteria (3 listed)

Patient must not use protocol-defined prohibited medicine
Patient is planning to receive an investigational drug at any time during the study
Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test

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: LinzessLinaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.	Drug	Linaclotide

Primary outcome

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: 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.

Results and safety

Results posted to the registry on 19 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overal Safey Population: Total	1,725	954

Primary outcome: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame: From first dose of open-label study drug up to 78 weeks. Count of participants. Unit: Participants

Measure	CC Safety Population: Total n = 607	IBS-C Safety Population: Total n = 1119	Overall Safety Population: Total n = 1725
Value	65	389	454

Population analysed: 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.

Adverse events

Time frame: From first dose of open-label study drug up to 78 weeks for adverse events (AEs) and within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CC Safety Population: Total	41 of 607 (6.8%)	283 of 607 (46.6%)	2 of 607
IBS-C Safety Population: Total	56 of 1,119 (5%)	572 of 1,119 (51.1%)	2 of 1,119
Overall Safety Population: Total	97 of 1,725 (5.6%)	855 of 1,725 (49.6%)	4 of 1,725

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Irritable Bowel Syndrome With Constipation

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2/3
Home Transcutaneous Electrical Acustimulation (TEA)
Irritable Bowel Syndrome With Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation

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.

Jeffrey M. Johnston, MD, FACP study chair

Ironwood Pharmaceuticals, Inc.

116 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 Irritable Bowel Syndrome With Constipation and Chronic Constipation, run by Ironwood Pharmaceuticals, Inc. at 116 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 7 inclusion and 3 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 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. 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 Feb 2018). 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?

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: From first dose of open-label study drug up to 78 weeks). 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 NCT00730171.

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 19 Feb 2018.