Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals

Vibrant

Status: Completed

Conditions: Chronic Idiopathic Constipation

Treatments: Device: vibrating capsule; Device: sham non-vibrating capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02030756

Vibrant-14-MS-CTIL

Details and patient eligibility

About

This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals

Enrollment: 144 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 years and older.
2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).
3. Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week.
4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms
5. Patient signed ICF
6. For women with childbearing potential, adequate contraception

Exclusion criteria

1. History of complicated/obstructive diverticular disease

2. History of intestinal or colonic obstruction.

3. History of significant GI disorder.

4. Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids

5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.

6. Presence of pacemaker.

7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

8. 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 GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.

9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)

10. Participation in another clinical study in the last 4 months prior to screening.

11. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.

12. Women who are pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups

Vibrating capsule

Active Comparator group

Description:

patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

Treatment:

Device: vibrating capsule

sham non-vibrating capsule

Sham Comparator group

Description:

patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

Treatment:

Device: sham non-vibrating capsule