Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00402337 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
310 participants (actual)
Sponsor
Ironwood Pharmaceuticals, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Nov 2006
Primary completion
Dec 2007
Completion
Feb 2008
First posted
22 Nov 2006 (estimated)
Last update posted
5 Mar 2013 (estimated)
Conditions
Chronic Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 2

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

    NCT00402337

    Nov 2006 to Feb 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • linaclotide acetateDrug
  • Matching placeboDrug

Arms5

  • Active comparator

    72 ug linaclotide acetate

  • Active comparator

    145 ug linaclotide acetate

  • Active comparator

    290 ug linaclotide acetate

  • Active comparator

    579 ug linaclotide acetate

  • Placebo comparator

    Matching Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency

    Time frame · Change from Baseline to Week 4

    Registry description

    Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

Secondary outcomes(5)

  1. SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

    Time frame · Change from Baseline to Week 4

    Registry description

    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.

  2. CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

    Time frame · Change from Baseline to Week 4

    Registry description

    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.

  3. Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period

    Time frame · Change from Baseline to Week 4

    Registry description

    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?

  4. Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period

    Time frame · Change from Baseline to Week 4

    Registry description

    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.

  5. Change From Baseline in Straining Score for the Treatment Period

    Time frame · Change from Baseline to Week 4

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Change from Baseline to Week 4

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

GroupValue (SBMs per week)Spread
Linaclotide, 72μg2.590.407
Linaclotide, 145μg3.250.412
Linaclotide, 290μg3.570.391
Linaclotide, 579μg4.290.394
Placebo1.450.383
Secondary and other outcome results(5)
Secondary outcomeNumber· Change from Baseline to Week 4

SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

GroupValue (participants)
Linaclotide, 72μg35
Linaclotide, 145μg31
Linaclotide, 290μg38
Linaclotide, 579μg42
Placebo22
Secondary outcomeNumber· Change from Baseline to Week 4

CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

GroupValue (participants)
Linaclotide, 72μg11
Linaclotide, 145μg15
Linaclotide, 290μg20
Linaclotide, 579μg18
Placebo5
Secondary outcomeLeast squares mean· Change from Baseline to Week 4

Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period

GroupValue (CSBMs per week)Spread
Linaclotide, 72μg1.470.295
Linaclotide, 145μg1.590.298
Linaclotide, 290μg1.750.283
Linaclotide, 579μg2.260.285
Placebo0.450.279
Secondary outcomeLeast squares mean· Change from Baseline to Week 4

Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period

GroupValue (units on a scale)Spread
Linaclotide, 72μg1.350.182
Linaclotide, 145μg1.570.177
Linaclotide, 290μg1.680.175
Linaclotide, 579μg2.000.171
Placebo0.500.170
Secondary outcomeLeast squares mean· Change from Baseline to Week 4

Change From Baseline in Straining Score for the Treatment Period

GroupValue (units on a scale)Spread
Linaclotide, 72μg-0.710.102
Linaclotide, 145μg-0.970.098
Linaclotide, 290μg-1.110.097
Linaclotide, 579μg-1.140.095
Placebo-0.520.094

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Linaclotide, 72μgLinaclotide, 72μg dose, oral administration, once per day–0 / 597 / 59
Linaclotide, 145μgLinaclotide, 145μg dose, oral administration, once per day–0 / 5611 / 56
Linaclotide, 290μgLinaclotide, 290μg dose, oral administration, once per day–0 / 625 / 62
Linaclotide, 579μgLinaclotide, 579μg dose, oral administration, once per day–0 / 6311 / 63
PlaceboDose-matched placebo, oral administration, once per day.–2 / 697 / 69

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

6 results

Efficacy of linaclotide for patients with chronic constipation.

Lembo et al. 2010Gastroenterologycited by 165

PMID 20045700DOI 10.1053/j.gastro.2009.12.050PUB-20045700

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.