Constipation
Conditions
Keywords
constipation, gastro, vibrating capsule, safety
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.
Interventions
DEVICEVibrant capsule
vibrating capsule
Sponsors
Vibrant Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Israel
Outcome results
None listed