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Trial record 2 of 2 for:    chronic constipation and vibrating capsule

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.

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 8, 2014
Last Update Posted Date November 7, 2017
Study Start Date  ICMJE July 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
Frequency of bowel movements [ Time Frame: 3 months ]
change in the frequency of bowel movements - weekly Spontaneous Bowel Movement (SBM) rate - from baseline to during treatment period
Change History Complete list of historical versions of study NCT02030756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
Official Title  ICMJE Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Idiopathic Constipation
Intervention  ICMJE
  • Device: vibrating capsule
    patients will receive 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)].
Study Arms  ICMJE
  • Active Comparator: Vibrating capsule
    patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
    Intervention: Device: vibrating capsule
  • Sham Comparator: sham non-vibrating capsule
    patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
    Intervention: Device: sham non-vibrating capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2014)
144
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2014)
80
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02030756
Other Study ID Numbers  ICMJE Vibrant-14-MS-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Vibrant Ltd.
Study Sponsor  ICMJE Vibrant Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vibrant Ltd.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP