Trial Outcomes & Findings for Vibrant Capsule vs. Placebo for Patient Suffering From Constipation (NCT NCT05036369)
NCT ID: NCT05036369
Last Updated: 2024-07-09
Results Overview
CSBM1 Success Rate: defined as the number of Participants with 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. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.
COMPLETED
NA
100 participants
up to 8 weeks of treatment
2024-07-09
Participant Flow
The study recruitment was conducted in 30 clinical sites in the USA from June 2021- September 2022
Following the consent process, subjects who met the study criteria started a run-in period of 2-4 weeks, during which they completed a daily eDiary with questions regrading their bowel movements and constipation symptoms.
Participant milestones
| Measure |
Active Capsule
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
56
|
|
Overall Study
COMPLETED
|
43
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Active Capsule
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
Overall Study
Run In non compliance
|
1
|
2
|
|
Overall Study
Change in eligibility criteria
|
0
|
1
|
Baseline Characteristics
Vibrant Capsule vs. Placebo for Patient Suffering From Constipation
Baseline characteristics by cohort
| Measure |
Active Capsule
n=44 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=56 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 12.87 • n=99 Participants
|
41.8 years
STANDARD_DEVIATION 11.65 • n=107 Participants
|
43.3 years
STANDARD_DEVIATION 12.27 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American or American Indian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/ Pacific Islander
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age of constipation onset (years)
|
33.1 years
STANDARD_DEVIATION 13.80 • n=99 Participants
|
29.6 years
STANDARD_DEVIATION 14.77 • n=107 Participants
|
31.2 years
STANDARD_DEVIATION 14.39 • n=206 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeks of treatmentPopulation: mITT
CSBM1 Success Rate: defined as the number of Participants with 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. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.
Outcome measures
| Measure |
Active Capsule
n=43 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=53 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
CSBM 1 Success Rate
|
24 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeks of treatmentCSBM2 Success Rate: defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.
Outcome measures
| Measure |
Active Capsule
n=43 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=53 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
CSBM2 Success Rate
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 10 weeksPopulation: mITT
Change from baseline in average straining based on the subject's account in daily diary reports. The straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining.
Outcome measures
| Measure |
Active Capsule
n=43 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=53 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
Straining Based on the Subject's Assessment Recorded in Daily Diaries
|
-2.4 units on a scale
Interval -3.14 to -1.66
|
-1.70 units on a scale
Interval -2.31 to -1.08
|
SECONDARY outcome
Timeframe: up to 8 weeks of treatmentCSBM1 expanded success rate, defined as the number of Participants with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.
Outcome measures
| Measure |
Active Capsule
n=43 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=53 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
CSBM1 Expanded Success Rate,
|
28 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeks of treatmentPopulation: mITT
defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.
Outcome measures
| Measure |
Active Capsule
n=43 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=53 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
CSBM2 Expanded Success Rate
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 10 weeksPopulation: mITT
Change from baseline in average stool consistency, using the Bristol Stool Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid
Outcome measures
| Measure |
Active Capsule
n=43 Participants
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=53 Participants
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
Change From Baseline in Stool Consistency
|
1.31 units on a scale
Interval 0.84 to 1.78
|
0.81 units on a scale
Interval 0.42 to 1.2
|
Adverse Events
Active Capsule
Placebo
Serious adverse events
| Measure |
Active Capsule
n=44 participants at risk
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=56 participants at risk
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
Renal and urinary disorders
Hospitalized due to bleeding from the catheter port
|
0.00%
0/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • Number of events 1 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
Other adverse events
| Measure |
Active Capsule
n=44 participants at risk
The Vibrant non-biodegradable capsule administrated twice a week
Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).
|
Placebo
n=56 participants at risk
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.8%
3/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Product Issues
Sensation of Vibration
|
15.9%
7/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Heartburn
|
2.3%
1/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Renal and urinary disorders
UTI
|
2.3%
1/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Esophageal Spasm
|
0.00%
0/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.8%
1/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
General disorders
Other
|
6.8%
3/44 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
8.9%
5/56 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Permission to use study data is required
- Publication restrictions are in place
Restriction type: OTHER