Irritable Bowel Syndrome With Constipation Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (PK) parameters of plecanatide of once daily oral 4 dose levels of plecanatide (0.5, 1.0, 2.0, or 3.0 mg) for 4 weeks as treatment in children 6 to <18 years of age with IBS-C. The study will include a 28-day Screening/Baseline Period, a 4 week treatment period, and a 2-week post-treatment follow-up period. Patients/caregivers will visit the clinic 4 times during the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00730171 -
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
|
Phase 3 | |
| Completed |
NCT00215566 -
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
|
Phase 2 | |
| Completed |
NCT00765999 -
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
|
Phase 3 | |
| Completed |
NCT02559206 -
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 2 | |
| Recruiting |
NCT05646186 -
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
|
N/A | |
| Completed |
NCT04026113 -
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
|
Phase 3 | |
| Recruiting |
NCT05519683 -
Home Transcutaneous Electrical Acustimulation (TEA)
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04166058 -
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
|
Phase 3 | |
| Completed |
NCT05164861 -
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
|
N/A | |
| Completed |
NCT04968652 -
IBS-C Questionnaire Study
|
||
| Completed |
NCT02590432 -
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
|
Phase 4 | |
| Terminated |
NCT02559817 -
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
|
Phase 2 | |
| Recruiting |
NCT05796388 -
A Study of Virtual Reality and Linaclotide for IBS-C
|
N/A | |
| Completed |
NCT00380250 -
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
|
Phase 3 | |
| Completed |
NCT04647045 -
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant
|
N/A | |
| Completed |
NCT03054506 -
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
|
N/A | |
| Recruiting |
NCT04214470 -
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS
|
||
| Not yet recruiting |
NCT06219707 -
Electro-acupuncture for Irritable Bowel Syndrome With Constipation
|
N/A | |
| Completed |
NCT04132804 -
Effect of Tai Chi as Treatment for IBS-C
|
N/A | |
| Completed |
NCT00938717 -
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
|
Phase 3 |