A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

Status

Completed

Phase

Phase 2

Enrollment

19 participants (actual)

Sponsor

AbbVie · Industry

Design

Randomized · Quadruple masking

Countries

7 countries

United States, Bulgaria, Croatia, Germany, Hungary, Serbia, United Kingdom

Start

27 Apr 2023

Primary completion

9 Jun 2025

Completion

9 Jun 2025

First posted

8 Mar 2023

Last update posted

6 Jan 2026

Conditions

Functional Constipation

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 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 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 regular 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.

• Experimental

  Part 1, Linaclotide Dose A

  Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks

• Experimental

  Part 1, Linaclotide Dose B

  Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks

• Experimental

  Part 1, Linaclotide Dose C

  Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks

• Experimental

  Part 2, Linaclotide

  Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks.

• Experimental

  Part 2, Placebo

  Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks.

1. Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period

   Time frame · Baseline to Week 4

   Registry description

   An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 4-week SBM frequency rate.

2. Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period

   Time frame · Baseline to Week 4

   Registry description

   The caregiver/parent/guardian/legally authorized representative (LAR) will rate and record in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid.

3. Change From Baseline in Straining During the Study Intervention Period

   Time frame · Baseline to Week 4

   Registry description

   Straining for each LAR/parent/guardian/caregiver-observed BM the child passes was collected daily in the eDiary device, using a 4-point scale (0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; 3 = I don't know) based on two questions (did he/she grunt or make a face like he/she was straining). Lower value represents a better outcome and "I don't know" is considered as a missing response. The subject's average straining score for each caregiver-observed BM was derived based on the average of non-missing responses of the two straining questions. The participant's straining score in the 4-week Study Intervention Period was the average of the non-missing average straining scores from all caregiver-observed SBMs during the 4-week Study Intervention Period. If a subject had no caregiver-observed SBMs at baseline, then the baseline straining score reported by the caregiver was missing and, therefore, that subject was not included in the change from baseline straining analysis.

4. Number of Participants With Adverse Events (AEs)

   Time frame · Up to Week 5

   Registry description

   An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

No study cites this trial.