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

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 14, 2019

Primary Completion Date

April 20, 2021

Study Completion Date

April 20, 2021

Conditions
Functional Constipation
Interventions
DRUG

Linaclotide

Linaclotide, capsules, mixed with water and administered orally, once daily in fasted state.

DRUG

Placebo

Matching placebo, capsules, mixed with water and administered orally, once daily in fasted state

Trial Locations (18)

10468

Advantage Clinical Trials, The Bronx

20910

Virgo Carter Pediatrics, Silver Spring

23220

Clinical Research Partners, LLC, Richmond

29414

Coastal Pediatric Research, Charleston

29464

Coastal Pediatric Research, Mt. Pleasant

30281

SleepCare Research Institute, Inc., Stockbridge

30513

River Birch Research Alliance, LLC, Blue Ridge

33155

South Miami Medical & Research Group, Inc., Miami

33166

Prohealth Research Center, Doral

35205

Central Research Associates, Inc, Birmingham

39150

David M. Headley, MD, P.A., Port Gibson

55413

Minnesota Gastroenterology PA, Minneapolis

71913

HealthStar Research, Hot Springs

72211

Preferred Clinical Research Partners, Little Rock

90723

Center for Clinical Trials, LLC, Paramount

92805

Advanced Research Center, Anaheim

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

07108

Foundation Pediatrics Med Clinical Research Partners, LLC, East Orange

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

Allergan

INDUSTRY