Chronic Idiopathic Constipation Clinical Trial
This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811
capsules in patients with chronic idiopathic constipation. Following a 2-week baseline
period, approximately 320 eligible patients with <3 complete spontaneous bowel movements
(CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the
following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by
a 2 week follow-up period.
The objectives of this study are:
- To assess the efficacy of YKP10811 once daily at relieving constipation and associated
symptoms in subjects with chronic idiopathic constipation.
- To determine the safety and tolerability of YKP10811 once daily in subjects with
chronic idiopathic constipation.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |
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 |
NCT03551873 -
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
|
||
| Completed |
NCT02819310 -
An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults
|
Phase 3 | |
| Completed |
NCT02819297 -
BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
|
Phase 3 |