CompletedPhase 2

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

United States35 participantsStarted 2019-10-14

Plain-language summary

The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.

Who can participate

Age range2 Years – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. History of retentive posturing or excessive volitional stool retention
✓. History of painful or hard bowel movements (BMs)
✓. Presence of a large fecal mass in the rectum
✓. History of large diameter stools that may obstruct the toilet
✓. At least one episode of fecal incontinence per week after the acquisition of toileting skills

Exclusion criteria

✕. Improvement with defecation
✕. Onset associated with a change in frequency of stool
✕. Onset associated with a change in form (appearance) of stool
✕. Surgery to remove a segment of the GI tract at any time before Screening (Visit 1)
✕. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit
✕. An appendectomy or cholecystectomy during the 60 days before Screening (Visit 1)
✕. Other major surgery during the 30 days before Screening (Visit 1)
✕. Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy

What they're measuring

Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort

Timeframe: Baseline (14 days prior to randomization) to Day 29

Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort

Timeframe: Baseline (14 days prior to randomization) to Day 29

Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort

Timeframe: Baseline (14 days prior to randomization) to Day 29

Percentage of Days With Fecal Incontinence During the Study Intervention Period (for Participants Who Have Acquired Toileting Skills During the Daytime and Nighttime or Acquired Toileting Skills During Daytime Only) Within Each Cohort

Timeframe: 29 Days

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: First dose of study drug intervention to within 1 week of last dose (Up to 45 days)

Trial details

NCT IDNCT04110145

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-20

Results submitted2022-03-31

View on ClinicalTrials.gov More Functional Constipation trials

Who can participate

Age range2 Years – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. History of retentive posturing or excessive volitional stool retention
✓. History of painful or hard bowel movements (BMs)
✓. Presence of a large fecal mass in the rectum
✓. History of large diameter stools that may obstruct the toilet
✓. At least one episode of fecal incontinence per week after the acquisition of toileting skills

Exclusion criteria

✕. Improvement with defecation
✕. Onset associated with a change in frequency of stool
✕. Onset associated with a change in form (appearance) of stool
✕. Surgery to remove a segment of the GI tract at any time before Screening (Visit 1)
✕. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit
✕. An appendectomy or cholecystectomy during the 60 days before Screening (Visit 1)
✕. Other major surgery during the 30 days before Screening (Visit 1)
✕. Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy

What they're measuring

Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort

Timeframe: Baseline (14 days prior to randomization) to Day 29

Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort

Timeframe: Baseline (14 days prior to randomization) to Day 29

Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort

Timeframe: Baseline (14 days prior to randomization) to Day 29

Timeframe: 29 Days

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: First dose of study drug intervention to within 1 week of last dose (Up to 45 days)