CompletedNot Applicable

Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

United States100 participantsStarted 2021-07-05

Plain-language summary

The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

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 IV criteria
✓. Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies
✓. Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week (as a result of at least 1 SBM and not more than 3 SBMs during each of the run-in weeks)
✓. Subjects above 50 years old or \<50 years old and with alarm signs should have colonoscopy performed within 10 years prior to study participation. Colonoscopy results should exclude GI obstruction and/or GI malignancy
✓. 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)
✕. Clinical evidence of current and significant 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, gastric electrical stimulator or any electrical implanted device.
✕. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

CSBM 1 Success Rate

Timeframe: up to 8 weeks of treatment

CSBM2 Success Rate

Timeframe: up to 8 weeks of treatment

NCT IDNCT05036369

SponsorVibrant Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-15

Results submitted2024-05-20

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 IV criteria
✓. Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies
✓. Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week (as a result of at least 1 SBM and not more than 3 SBMs during each of the run-in weeks)
✓. Subjects above 50 years old or \<50 years old and with alarm signs should have colonoscopy performed within 10 years prior to study participation. Colonoscopy results should exclude GI obstruction and/or GI malignancy
✓. 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)
✕. Clinical evidence of current and significant 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, gastric electrical stimulator or any electrical implanted device.
✕. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.