Chronic Idiopathic Constipation Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation
The purpose of this study was to evaluate the efficacy and safety of oral administration of lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.
The drug being tested in this study is called lubiprostone. Lubiprostone is being tested to
treat people who have chronic idiopathic constipation. This study will look at the frequency
of spontaneous bowel movements (SBMs) in people who take lubiprostone compared to placebo.
The study will enroll 150 participants. Participants will be randomly assigned (by chance,
like flipping a coin) equally to one of the two treatment groups, which will remain
undisclosed to the patient and study doctor during the study (unless there is an urgent
medical need):
- Lubiprostone 24 μg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has
no active ingredient
All participants will be asked to take one capsule with breakfast and one capsule with dinner
each day throughout the study. All participants will be asked to record each time they have a
SBM and all details of each SBM (including the consistency of the stool and the difficulty
they have in passing it) in a diary.
This multi-center trial will be conducted in South Korea. The overall time to participate in
this study is 8 weeks. Participants will make multiple visits to the clinic, and will be
contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
;
| 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 |
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 |