Part 1 Linaclotide for Functional Constipation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Functional Constipation+1 MoreLinaclotide - Drug
Eligibility
2 - 5
All Sexes
What conditions do you have?
Select

Study Summary

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 100 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligible Conditions
  • Functional Constipation
  • Chronic Idiopathic Constipation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline to Week 12

Baseline to Week 12
Change from baseline in stool consistency during the double blind study intervention period
Change from baseline in straining during the double-blind study intervention period
Change from baseline in the spontaneous bowel movement (SBM) frequency rate (SBMs/week) during the double-blind study intervention period.
Proportion of days with fecal incontinence during the double-blind study intervention period (for participants who have acquired toileting skills during daytime and nighttime or acquired toileting skills during daytime only)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Part 1 Placebo
1 of 3
Part 1 Linaclotide
1 of 3
Part 2 Linaclotide
1 of 3

Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: Part 1 Linaclotide · Has Placebo Group · Phase 3

Part 1 Placebo
Drug
Experimental Group · 1 Intervention: Placebo for Linaclotide · Intervention Types: Drug
Part 1 Linaclotide
Drug
Experimental Group · 1 Intervention: Linaclotide · Intervention Types: Drug
Part 2 Linaclotide
Drug
Experimental Group · 1 Intervention: Linaclotide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Linaclotide
2008
Completed Phase 4
~9200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 12

Who is running the clinical trial?

AbbVieLead Sponsor
836 Previous Clinical Trials
471,649 Total Patients Enrolled
Ironwood Pharmaceuticals, Inc.Industry Sponsor
38 Previous Clinical Trials
16,506 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
305 Previous Clinical Trials
119,083 Total Patients Enrolled

Eligibility Criteria

Age 2 - 5 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A substantial amount of fecal matter has accumulated in your rectum.
You have a history of producing stools with larger than average diameters.
You experience one or more episodes of fecal incontinence per week since gaining control over your bowel movements.
A willing and able caregiver/parent/guardian/LAR is required to complete any screening or study-specific procedures, as well as read, understand, and be trained in the assessments found on the eDiary device.
You have a history of either holding onto postures for too long, or having difficulty controlling your bowel movements.
You have experienced discomfort or difficulty with bowel movements.