Safety Evaluation of the Vibrating Capsule

Constipation Clinical Trial

— Vibrant  

Official title:

Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306448
• Other study ID #: Vibrant-09-MS-CTIL
• Status: Completed
• Phase: N/A
• First received: February 21, 2011
• Last updated: December 9, 2014
• Start date: March 2011
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Vibrant Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Device:
• Vibrant capsule
vibrating capsule

Locations

Country	Name	City	State
Israel	Barzilai MC	AShkelon
Israel	Italian Hospital	Nazeret
Israel	Tel Aviv Souraski medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Vibrant Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events	Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements	7.5 weeks of treatment period	Yes
Secondary	Change in spontaneous bowel movement per week compared to baseline	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	9.5 weeks	No
Secondary	Patient assessment of capsule tolerability	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.	7.5 weeks of treatment period	No