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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02030756
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Vibrant Ltd.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Device: vibrating capsule Device: sham non-vibrating capsule Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
 Device: vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
Sham Comparator: sham non-vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
 Device: sham non-vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of bowel movements [ Time Frame: 3 months ]
    change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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

12. 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.

13. Women who are pregnant or lactating.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030756


Locations
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Sponsors and Collaborators
Vibrant Ltd.
More Information
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Responsible Party: Vibrant Ltd.
ClinicalTrials.gov Identifier: NCT02030756    
Other Study ID Numbers: Vibrant-14-MS-CTIL
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Vibrant Ltd.:
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive