Clinical Trials Logo
  1. Home
  2. Chronic Idiopathic Constipation
  3. NCT03551873

A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

Chronic Idiopathic Constipation Clinical Trial

Official title:
A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE

Clinical Trial Summary

This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE

Clinical Trial Description

This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03551873
Study type Observational
Source Bausch Health Americas, Inc.
Contact
Status Completed
Phase
Start date June 21, 2018
Completion date December 14, 2018
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02361749 - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation Phase 4
Terminated NCT02239510 - Efficacy of Linaclotide to Senna for CIC N/A
Completed NCT01895543 - Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation Phase 3
Completed NCT01460225 - Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation Phase 4
Completed NCT02291679 - Trial of Linaclotide in Patients With Chronic Idiopathic Constipation Phase 3
Completed NCT01989234 - A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation Phase 2
Completed NCT01993875 - Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation Phase 3
Completed NCT01674530 - Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation Phase 3
Completed NCT01429987 - The Plecanatide Chronic Idiopathic Constipation (CIC) Study Phase 2/Phase 3
Completed NCT01982240 - 12-Week Study of Plecanatide for CIC (The CIC3 Study) Phase 3
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
Completed NCT02481947 - A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults Phase 3
Completed NCT01372423 - Evaluation of Clinical Equivalence Between Two Lubiprostone Products Phase 3
Completed NCT03054506 - The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation N/A
Recruiting NCT04804267 - Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation Phase 3
Completed NCT03879239 - Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation N/A
Completed NCT01053962 - SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation Phase 2
Completed NCT03097861 - Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo Phase 3
Completed NCT02819297 - BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults Phase 3
Completed NCT02819310 - An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults Phase 3