Constipation
Conditions
Brief summary
The study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.
Detailed description
One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2 days, followed by one day without, one per day for 2 days followed by one day without, etc. (14 capsules in 3 weeks). The study will have one interim analysis. Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks. Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation. After 14 days the patients will return and eligibility will be re-assessed. Patients will be trained on how to use the base unit. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period. Patients will receive phone calls up to twice per week and patient compliance will be monitored during the 8 weeks of the study.
Interventions
DEVICEVibrating Capsule
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Sponsors
Vibrant Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 22 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 used for at least one month at recommended dose) 3. Patients with an average of less than 3 Spontaneous Bowel Movements per week and at least 1 Spontaneous Bowel Movements per week 4. Normal colonoscopy performed within 10 years prior to study participation, unless the patients are less than 50 years old and without alarm signs and/or symptoms 5. Patient signed the Informed Consent Form 6. Female subjects must have a negative urine pregnancy test 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; in these circumstances, a urine pregnancy test will not be necessary.
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: chronic use is defined as taking full dose non-steroidal anti-inflammatory drugs more than three times a week for at least six months. Patients on cardiac doses of aspirin may be enrolled in the study 12. Patients with pelvic floor dysfunction/defecatory disorder, based on patient history 13. Participation in another clinical study within one month prior to screening. 14. Women who are pregnant or lactating 15. Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules 16. 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 17. 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 study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Bowel Movements Success Rate | 6 weeks of treatment | Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vibrating Capsule Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Vibrating Capsule: Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Vibrating Capsule |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 12.52 |
| Duration of constipation (years) | 12.2 years STANDARD_DEVIATION 11.18 |
| Race/Ethnicity, Customized Cacucasian | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 21 Participants |
| Race/Ethnicity, Customized Native American or American Indian | 1 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Spontaneous Bowel Movements Success Rate
Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable.
Time frame: 6 weeks of treatment
Population: subjects with an improvement of at least 1 SBM a week, 3 out of 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vibrating Capsule | Spontaneous Bowel Movements Success Rate | 21 Participants |