Status:
COMPLETED
Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)
Lead Sponsor:
Vibrant Ltd.
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
22+ years
Phase:
PHASE4
Brief Summary
The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.
Detailed Description
Visit 1 -Screening: Subjects will be screened to the study at the screening visit, PAC-QOL questionnaire will be completed and subject will have a run-in time for a period of 2-3 weeks, assuring 14 co...
Eligibility Criteria
Inclusion
- Subjects aged 22 years and older
- Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose)
- Subjects with an average of \<3 Spontaneous Bowel Movements (SBM) per week
- Normal colonoscopy performed within 5 years prior to study participation, unless the subjects are \<50 years old and without alarm signs and/or symptoms
- Subject signed the Informed Consent Form (ICF)
- Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record \[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\]; in these circumstances, a pregnancy test will not be necessary
Exclusion
- History of complicated/obstructive diverticular disease
- History of intestinal or colonic obstruction, or suspected intestinal obstruction.
- History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
- History of gastroparesis
- Use of any of the following medications:
- Medications that may affect intestinal motility, prokinetics, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
- With the exception of antidepressants, thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.
- Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
- Presence of cardiac pacemaker or gastric electrical stimulator.
- History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
- Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
- History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
- Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history
- Participation in another clinical study within one month prior to screening.
- Women who are pregnant or lactating
- Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules
- Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage
- Subject participated in a previous Vibrant study
- Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
Key Trial Info
Start Date :
July 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04458675
Start Date
July 26 2018
End Date
March 30 2019
Last Update
June 14 2024
Active Locations (1)
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1
Health Research of Hampton Roads
Newport News, Virginia, United States, 23606