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
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
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. ;
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 |
NCT01993875 -
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects 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 |
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 |