Chronic ConstipationPhase 2NCT00402337

Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

A Phase 2 study testing linaclotide acetate in people with Chronic Constipation, run by Ironwood Pharmaceuticals, Inc. at 60 sites in United States.

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

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Constipation
What is being tested?: linaclotide acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 310 participants
Where: 60 sitesUnited States
Study dates: Nov 2006to Feb 2008
Phase: Phase 2
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 is 18 years of age or older
Patient meets colonoscopy requirements according to the American Gastroenterological Association
Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
Patient is fluent in English

Who cannot join

Patient reports loose or watery stools
Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
Patient may not take prohibited medications per protocol
Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

United States60 sites

Microbia Investigational Site
Anaheim, California
Microbia Investigational Site
Anderson, South Carolina
Microbia Investigational Site
Ann Arbor, Michigan
Microbia Investigational Site
Asheville, North Carolina, 28801
Microbia Investigational Site
Austin, Texas, 78745
Microbia Investigational Site
Boston, Massachusetts
Microbia Investigational Site
Boulder, Colorado
Microbia Investigational Site
Boynton Beach, Florida
Microbia Investigational Site
Bristol, Connecticut, 06011
Microbia Investigational Site
Bristol, Tennessee
Microbia Investigational Site
Chapel Hill, North Carolina, 9199668328
Microbia Investigational Site
Charlotte, North Carolina, 28075
Microbia Investigational Site
Chattanooga, Tennessee
Microbia Investigational Site
Chesapeake, Virginia, 23320
Microbia Investigational Site
Cincinnati, Ohio
Microbia Investigational Site
Clive, Iowa
Microbia Investigational Site
Columbia, South Carolina
Microbia Investigational Site
Corsicana, Texas, 75110
Microbia Investigational Site
Davenport, Iowa
Microbia Investigational Site
Dayton, Ohio, 45440
Microbia Investigational Site
El Paso, Texas
Microbia Investigational Site
Fayetteville, North Carolina
Microbia Investigational Site
Germantown, Tennessee
Microbia Investigational Site
Great Neck, New York
Microbia Investigational Site
Greensboro, North Carolina
Microbia Investigational Site
Huntsville, Alabama, 35801
Microbia Investigational Site
Indianapolis, Indiana, 46237
Microbia Investigational Site
Jackson, Tennessee, 38301
Microbia Investigational Site
La Crosse, Wisconsin, 54601
Microbia Investigational Site
Lincoln, Nebraska
Microbia Investigational Site
Louisville, Kentucky
Microbia Investigational Site
Lynchburg, Virginia, 24502
Microbia Investigational Site
Madison, Wisconsin
Microbia Investigational Site
Monroe, Louisiana, 71201
Microbia Investigational Site
Ogden, Utah
Microbia Investigational Site
Oklahoma City, Oklahoma, 73104
Microbia Investigational Site
Oklahoma City, Oklahoma, 73112
Microbia Investigational Site
Oklahoma City, Oklahoma, 73116
Microbia Investigational Site
Olive Branch, Mississippi
Microbia Investigational Site
Olympia, Washington
Microbia Investigational Site
Peoria, Illinois, 61602
Microbia Investigational Site
Pittsburgh, Pennsylvania
Microbia Investigational Site
Pittsford, New York
Microbia Investigational Site
Port Orange, Florida
Microbia Investigational Site
Raleigh, North Carolina, 27612
Microbia Investigational Site
Sacramento, California
Microbia Investigational Site
San Antonio, Texas
Microbia Investigational Site
San Diego, California
Microbia Investigational Site
Sellersville, Pennsylvania
Microbia Investigational Site
Sherwood, Arkansas, 72120
Microbia Investigational Site
Silver Spring, Maryland, 20901
Microbia Investigational Site
Simpsonville, South Carolina
Microbia Investigational Site
Spokane, Washington
Microbia Investigational Site
Stockbridge, Georgia, 30281
Microbia Investigational Site
Summerville, South Carolina, 29485
Microbia Investigational Site
Tampa, Florida
Microbia Investigational Site
Traverse City, Michigan, 49684
Microbia Investigational Site
Tucson, Arizona, 85715
Microbia Investigational Site
Tulsa, Oklahoma, 74104
Microbia Investigational Site
Winston-Salem, North Carolina, 27103

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About this study

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Conditions: Chronic Constipation
Being tested: linaclotide acetate, Matching placebo
Keywords: Constipation, Chronic Constipation, Microbia, linaclotide, linaclotide acetate, MD-1100
Medical subject headings: Constipation

What participants receive

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

linaclotide acetateDrug
oral, once daily.
Matching placeboDrug
oral, once daily

Study groups in NCT00402337
Study group	Role	What they receive
72 ug linaclotide acetate	Active comparator	Not described Receives: Drug: linaclotide acetate
145 ug linaclotide acetate	Active comparator	Not described Receives: Drug: linaclotide acetate
290 ug linaclotide acetate	Active comparator	Not described Receives: Drug: linaclotide acetate
579 ug linaclotide acetate	Active comparator	Not described Receives: Drug: linaclotide acetate
Matching Placebo	Placebo comparator	Not described Receives: Drug: Matching placebo

What is being measured

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

Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.
Measured: Change from Baseline to Week 4

Secondary outcomes (5)

SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks.
For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate.
Measured: Change from Baseline to Week 4
CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks.
For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate.
Measured: Change from Baseline to Week 4
Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period
CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?
Measured: Change from Baseline to Week 4
Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period
Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = 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; and 7 = entirely liquid.
Measured: Change from Baseline to Week 4
Change From Baseline in Straining Score for the Treatment Period
Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.
Measured: Change from Baseline to Week 4

Timeline

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

Nov 2006Feb 2008

First posted22 Nov 2006 (estimated)
Study startNov 2006
Primary completionDec 2007
Study completionFeb 2008

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 Chronic 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402337
Sponsor's protocol ID: MCP-103-201
Status last verified: Jan 2013
First submitted: 18 Nov 2006
Last updated: 5 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.
PubMed 20045700

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

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic 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)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
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
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation

All Chronic Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
ClinicalTrials.gov ID: NCT00402337
Acronym / sponsor ID: MCP-103-201
Conditions: Chronic Constipation
Keywords: Constipation, Chronic Constipation, Microbia, linaclotide, linaclotide acetate, MD-1100
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Dec 2007 (actual)
Study completion: Feb 2008 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 5 Mar 2013

Clinical summary

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

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
72 ug linaclotide acetate	Active comparator	Drug: linaclotide acetate
145 ug linaclotide acetate	Active comparator	Drug: linaclotide acetate
290 ug linaclotide acetate	Active comparator	Drug: linaclotide acetate
579 ug linaclotide acetate	Active comparator	Drug: linaclotide acetate
Matching Placebo	Placebo comparator	Drug: Matching placebo

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 is 18 years of age or older
Patient meets colonoscopy requirements according to the American Gastroenterological Association
Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
Patient is fluent in English

Key exclusion criteria (4 listed)

Patient reports loose or watery stools
Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
Patient may not take prohibited medications per protocol
Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

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
linaclotide acetateoral, once daily.	Drug	145 ug linaclotide acetate, 290 ug linaclotide acetate, 579 ug linaclotide acetate, 72 ug linaclotide acetate
Matching placebooral, once daily	Drug	Matching Placebo

Primary outcome

Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
Time frame: Change from Baseline to Week 4
Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

5 secondary outcomes

SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
Time frame: Change from Baseline to Week 4
CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
Time frame: Change from Baseline to Week 4
Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period
Time frame: Change from Baseline to Week 4
Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period
Time frame: Change from Baseline to Week 4
Change From Baseline in Straining Score for the Treatment Period
Time frame: Change from Baseline to Week 4

Results and safety

Results posted to the registry on 5 Mar 2013, 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, 72μg	59	54
Linaclotide, 145μg	57	51
Linaclotide, 290μg	62	58
Linaclotide, 579μg	63	51
Placebo	69	61

Primary outcome: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency

Time frame: Change from Baseline to Week 4. Least squares mean (Standard Error). Unit: SBMs per week

Measure	Linaclotide, 72μg n = 59	Linaclotide, 145μg n = 56	Linaclotide, 290μg n = 62	Linaclotide, 579μg n = 62	Placebo n = 68
Value	2.59 (0.407)	3.25 (0.412)	3.57 (0.391)	4.29 (0.394)	1.45 (0.383)

Linaclotide, 72μg vs Placebo: p = 0.0337, ANCOVA
Linaclotide, 145μg vs Placebo: p = 0.0010, ANCOVA
Linaclotide, 290μg vs Placebo: p <0.0001, ANCOVA

Population analysed: 307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 "How many bowel movements did you have today or yesterday since your last call?" were included in the intent-to-treat (ITT) Population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from November of 2006 to February of 2008.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linaclotide, 72μg	0 of 59 (0%)	7 of 59 (11.9%)	Not reported
Linaclotide, 145μg	0 of 56 (0%)	11 of 56 (19.6%)	Not reported
Linaclotide, 290μg	0 of 62 (0%)	5 of 62 (8.1%)	Not reported
Linaclotide, 579μg	0 of 63 (0%)	11 of 63 (17.5%)	Not reported
Placebo	2 of 69 (2.9%)	7 of 69 (10.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20045700Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.

Related trials for Chronic Constipation

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic 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)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
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
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
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.

Microbia Medical Affairs study director

Microbia, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing linaclotide acetate in people with Chronic Constipation, run by Ironwood Pharmaceuticals, Inc. at 60 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 4 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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Mar 2013). 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?

Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency (time frame: Change from Baseline to Week 4). 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 NCT00402337, 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 5 Mar 2013.