Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation

2019-03-22 06:26:19 | BioPortfolio


The study is a prospective, randomized, multicenter, adaptive design, single 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 will come 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 will be 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.

Study Design


Chronic Idiopathic Constipation


Vibrating capsule


Not yet recruiting


Vibrant Ltd.

Results (where available)

View Results


Published on BioPortfolio: 2019-03-22T06:26:19-0400

Clinical Trials [1530 Associated Clinical Trials listed on BioPortfolio]

Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week,Bristol score,and Colon transm...

The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or le...

A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipati...

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is th...

SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects o...

PubMed Articles [7482 Associated PubMed Articles listed on BioPortfolio]

Evaluating When and Why Patients Discontinue Chronic Therapy for Irritable Bowel Syndrome With Constipation and Chronic Idiopathic Constipation.

To inform the patient-centered discussion regarding comparative outcomes with irritable bowel syndrome/chronic idiopathic constipation pharmacotherapy, we evaluated reasons and timing of discontinuati...

An overview of the efficacy and safety of prucalopride for the treatment of chronic idiopathic constipation.

: Chronic idiopathic constipation (CIC) is a kind of constipation in which the patient experiences constipation more than 3 months without any identifiable cause. Prucalopride is one such treatment co...

Blunted Evoked Prouroguanylin Endocrine Secretion in Chronic Constipation.

Prouroguanylin (ProUGN) in the intestine is cleaved to form uroguanylin (UGN), which stimulates guanylate cyclase C (GUCY2C), inducing cyclic guanosine monophosphate signaling. Paracrine release regul...

Frequency of Eating Disorder Pathology Among Patients With Chronic Constipation and Contribution of Gastrointestinal-Specific Anxiety.

Individuals with eating disorders (EDs) frequently have constipation-related symptoms, although the mechanisms of this relationship are not clear. We examined the frequency of and relation between EDs...

Normal colonic transit time predicts the outcome of colonic manometry in patients with chronic constipation-an exploratory study.

Colonic manometry (CM) can be of additive value in the diagnostic workup of colonic motility in chronic constipated patients. However, it is claimed that colonic motor disturbances occur in normal-tra...

Medical and Biotech [MESH] Definitions

Dilatation of the COLON, often to alarming dimensions. There are various types of megacolon including congenital megacolon in HIRSCHSPRUNG DISEASE, idiopathic megacolon in CONSTIPATION, and TOXIC MEGACOLON.

Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.

Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.

Neurologic conditions in adults associated with acute or chronic exposure to lead or any of its salts. The most common lead related neurologic syndrome in adults consists of a polyneuropathy involving motor fibers. This tends to affect distal nerves and may present as wrist drop due to RADIAL NEUROPATHY. Additional features of chronic lead exposure include ANEMIA; CONSTIPATION; colicky abdominal pain; a bluish lead line of the gums; interstitial nephritis (NEPHRITIS, INTERSTITIAL); and saturnine gout. An encephalopathy may rarely occur. (From Adams et al., Principles of Neurology, 6th ed, p1212)

A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.

More From BioPortfolio on "Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation"

Quick Search

Searches Linking to this Trial