CompletedPhase 4

Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

United States59 participantsStarted 2018-07-26

Plain-language summary

The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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:
✕. 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.

CSBM1 Success Rate

Timeframe: 8 weeks

CSBM2 Success Rate:

Timeframe: 8 weeks

NCT IDNCT04458675

SponsorVibrant Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-07

Results submitted2024-05-21

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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:
✕. 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.