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Guanylate Cyclase-C Agonist

Linaclotide for Pediatric Constipation

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a large fecal mass in the rectum.

History of large diameter stools.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of Linaclotide for children with functional constipation. Kids will take Linaclotide or placebo for 12 weeks, then switch to Linaclotide for 24 weeks. Medical assessments, tests and questionnaires will be used to check the effect of the treatment.

Who is the study for?

This trial is for children aged 2 to 5 with functional constipation, meeting specific criteria like having fewer than two bowel movements per week without laxatives. They must not have certain conditions like cystic fibrosis or untreated hypothyroidism, and their caregiver must be able to use an eDiary.Check my eligibility

What is being tested?

The study tests Linaclotide against a placebo in young children with functional constipation. It's split into two parts: the first part randomly assigns participants to either the drug or placebo for 12 weeks; the second part gives all participants Linaclotide for another 24 weeks.See study design

What are the potential side effects?

Possible side effects of Linaclotide may include diarrhea, abdominal pain, gas, bloating, and possibly allergic reactions. The severity can vary from child to child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a significant blockage in my rectum.

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I have a history of large stools.

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I experience at least one episode of losing control over bowel movements weekly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in the spontaneous bowel movement (SBM) frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.

Secondary outcome measures

Change from baseline in stool consistency observed by the primary caregiver during the double blind study intervention period

Change from baseline in straining observed by the primary caregiver 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 Design

3Treatment groups

Experimental Treatment

Group I: Part 2 LinaclotideExperimental Treatment1 Intervention

Participants who completed study intervention in Part 1 of this study or the Phase 2 Study LIN-MD-67 will receive 24 weeks of linaclotide exposure.

Group II: Part 1 PlaceboExperimental Treatment1 Intervention

Participants will receive placebo for 12 weeks.

Group III: Part 1 LinaclotideExperimental Treatment1 Intervention

Participants will receive linaclotide for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Linaclotide

2008

Completed Phase 4

~9200

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,274 Total Patients Enrolled

Ironwood Pharmaceuticals, Inc.Industry Sponsor

41 Previous Clinical Trials

16,913 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,993 Total Patients Enrolled

Media Library

Linaclotide (Guanylate Cyclase-C Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05652205 — Phase 3

Functional Constipation Research Study Groups: Part 2 Linaclotide, Part 1 Placebo, Part 1 Linaclotide

Functional Constipation Clinical Trial 2023: Linaclotide Highlights & Side Effects. Trial Name: NCT05652205 — Phase 3

Linaclotide (Guanylate Cyclase-C Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05652205 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have a minimum age requirement and, if so, can persons aged 45+ fulfill the criteria?

"This clinical trial is enrolling children between the ages of two and five years old."

Answered by AI

Is Part 2 Linaclotide considered a secure medication for patients?

"Part 2 Linaclotide has been provided a score of 3 on our company's safety scale due to the presence of previous data surrounding its efficacy and multiple studies affirming its security."

Answered by AI

How many places can participants access this clinical trial?

"21 clinical trial sites have been approved to enroll patients, with G & L Research LLC /ID# 250658 in Foley, South Miami Medical & Research Group Inc. /ID# 249418 in Miami and Frontier Clinical Research/ ID #250657 in Smithfield being the primary locations."

Answered by AI

Are participants being welcomed to join this experiment currently?

"As evidenced by the clinicaltrials.gov website, enrolment for this particular trial has been concluded; it was initially posted on December 16th 2022 and its last update occurred on December 6th 2022. However, there are 76 other trials recruiting participants currently available."

Answered by AI

Does my medical history satisfy the requirements for entrance into this clinical trial?

"This trial is looking to recruit 100 children between the ages of two and five that are currently suffering from chronic idiopathic constipation (CIC). In addition, these participants must present a large fecal mass in their rectum, have a history of producing sizable stools, experience at least one episode of faecal incontinence per week after developing toileting skills and be accompanied by an adult willing and able to fulfil protocol requirements. Furthermore, this accompanying person needs to understand eDiary assessments as well as partake in associated training. Finally, candidates should display retentive posturing or volitional stool retention alongside painful or"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

2022. "A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05652205.

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