Safety Evaluation of the Vibrating Capsule

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Device: Vibrant capsule

• Registration Number: NCT01306448
• Lead Sponsor: Vibrant Ltd.

Brief Summary

The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.

Detailed Description

Healthy volunteers will be followed for safety for 7 days after taking the capsule.

Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.

Study Timeline

• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-28
• Study Start: 2011-03
• Study First Posted: 2011-03-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients age 18-60 years
• Ability of subject to understand character and individual consequences of clinical trial
• Written informed consent must be available before enrollment in the trial
• For women with childbearing potential, adequate contraception

Exclusion Criteria

• Patient with Diverticulosis
• Patient must not use protocol-defined prohibited medicine
• History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
• Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
• Presents of pacemakers
• History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
• Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia.
• Actively participating in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vibrating capsule	Vibrant capsule	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	7.5 weeks of treatment period	Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements

Secondary Outcome Measures

Name	Time	Method
Patient assessment of capsule tolerability	7.5 weeks of treatment period	Comfort and tolerability will be assessed by the patient. Tolerability evaluation will include: assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life.
Change in spontaneous bowel movement per week compared to baseline	9.5 weeks	Efficacy will be assessed by increase of more than one complete spontaneous bowel movement per week during the 7.5 weeks of treatment compared to 2 weeks baseline

Trial Locations

Locations (3)

Italian Hospital; 🇮🇱 Nazeret, Israel

Tel Aviv Souraski medical Center; 🇮🇱 Tel Aviv, Israel

Barzilai MC; 🇮🇱 AShkelon, Israel