Chronic Idiopathic Constipation Clinical Trial
Official title:
A Prospective, Randomized, Multi-center, Double-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation
The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
Subjects came for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks Three arms were assessed: - Vibrant Capsule mode A administered 5 times per week - Vibrant Capsule mode B administered 5 times per week - Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time. Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm. ;
| 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 |
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 |
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 |