Constipation
Conditions
Brief summary
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Two arms will be assessed: * Vibrant Capsule administered 5 times per week * Sham Capsule administered 5 times per week
Detailed description
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Two arms will be assessed: * Vibrant Capsule administered 5 times per week * Sham Capsule administered 5 times per week Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks. Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period. After the 14 days of run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit. Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period. Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.
Interventions
DEVICEVibrant capsule
One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
DEVICESham capsule
One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.
Sponsors
Vibrant Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 22 years and older 2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies 3. Subjects with an average of \<3 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week 4. Normal colonoscopy performed within 10 years prior to study participation, unless the subjects are \<50 years old and without alarm signs and/or symptoms 5. Subject signed the Informed Consent Form (ICF) 6. Female subjects must have a negative pregnancy test
Exclusion criteria
1. History of complicated/obstructive diverticular disease 2. History of intestinal or colonic obstruction, or suspected intestinal obstruction. 3. 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) 4. History of gastroparesis 5. Use of any of the following medications: * Medications that may affect intestinal motility, prokinetics, anti-depressants, 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. 6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease. 7. Presence of cardiac pacemaker or gastric electrical stimulator. 8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating. 9. 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 10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia 11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) 12. Subjects with pelvic floor dysfunction/defecatory disorder 13. Participation in another clinical study within one month prior to screening. 14. Women who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment | 8 weeks | CSBM1 success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment |
| CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment | 8 Weeks | CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vibrant Capsule Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment
Vibrant capsule: One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment. | 89 |
| Sham Capsule Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment
Sham capsule: One Sham capsule will be ingested 5 times per week for 8 weeks of treatment. | 93 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 12 |
| Overall Study | Noncompliance | 1 | 3 |
| Overall Study | Protocol Violation | 4 | 8 |
| Overall Study | Technical issue | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Vibrant Capsule | Sham Capsule | Total |
|---|---|---|---|
| Age, Continuous | 45.36 Years STANDARD_DEVIATION 13.08 | 42.67 Years STANDARD_DEVIATION 11.16 | 43.99 Years STANDARD_DEVIATION 12.17 |
| Duration of constipation | 11.67 years STANDARD_DEVIATION 12.46 | 13.09 years STANDARD_DEVIATION 12.19 | 12.40 years STANDARD_DEVIATION 12.31 |
| Race/Ethnicity, Customized Asian/ Pacific Islander | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 32 Participants | 33 Participants | 65 Participants |
| Race/Ethnicity, Customized Caucasian | 37 Participants | 29 Participants | 66 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 17 Participants | 22 Participants | 39 Participants |
| Race/Ethnicity, Customized Native or Indian American | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 89 participants | 93 participants | 182 participants |
| Sex: Female, Male Female | 71 Participants | 71 Participants | 142 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 93 |
| other Total, other adverse events | 28 / 89 | 19 / 93 |
| serious Total, serious adverse events | 1 / 89 | 1 / 93 |
Outcome results
Primary
CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
CSBM1 success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vibrant Capsule | CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment | 24 Participants |
| Sham Capsule | CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment | 33 Participants |
Primary
CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
Time frame: 8 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vibrant Capsule | CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment | 16 Participants |
| Sham Capsule | CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment | 26 Participants |