Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week (NCT NCT03031301)
NCT ID: NCT03031301
Last Updated: 2024-07-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
93
|
|
Overall Study
COMPLETED
|
71
|
65
|
|
Overall Study
NOT COMPLETED
|
18
|
28
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
12
|
|
Overall Study
Noncompliance
|
1
|
3
|
|
Overall Study
Technical issue
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
Baseline characteristics by cohort
| Measure |
Vibrant Capsule
n=89 Participants
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.
|
Sham Capsule
n=93 Participants
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.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.36 Years
STANDARD_DEVIATION 13.08 • n=93 Participants
|
42.67 Years
STANDARD_DEVIATION 11.16 • n=4 Participants
|
43.99 Years
STANDARD_DEVIATION 12.17 • n=27 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
17 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
32 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native or Indian American
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian/ Pacific Islander
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=93 Participants
|
93 participants
n=4 Participants
|
182 participants
n=27 Participants
|
|
Duration of constipation
|
11.67 years
STANDARD_DEVIATION 12.46 • n=93 Participants
|
13.09 years
STANDARD_DEVIATION 12.19 • n=4 Participants
|
12.40 years
STANDARD_DEVIATION 12.31 • n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeksCSBM1 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
Outcome measures
| Measure |
Vibrant Capsule
n=89 Participants
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.
|
Sham Capsule
n=93 Participants
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.
|
|---|---|---|
|
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
|
33 Participants
|
PRIMARY outcome
Timeframe: 8 WeeksCSBM2 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
Outcome measures
| Measure |
Vibrant Capsule
n=89 Participants
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.
|
Sham Capsule
n=93 Participants
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.
|
|---|---|---|
|
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
|
26 Participants
|
Adverse Events
Vibrant Capsule
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Sham Capsule
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vibrant Capsule
n=89 participants at risk
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.
|
Sham Capsule
n=93 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Traumatic Fracture Of Pelvis
|
1.1%
1/89 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Psychiatric disorders
Anxiety Attack
|
0.00%
0/89 • 8 weeks
|
1.1%
1/93 • 8 weeks
|
Other adverse events
| Measure |
Vibrant Capsule
n=89 participants at risk
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.
|
Sham Capsule
n=93 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.9%
7/89 • Number of events 8 • 8 weeks
|
2.2%
2/93 • Number of events 2 • 8 weeks
|
|
Product Issues
Sensation of vibration
|
16.9%
15/89 • Number of events 30 • 8 weeks
|
2.2%
2/93 • Number of events 2 • 8 weeks
|
|
Gastrointestinal disorders
Bloating
|
2.2%
2/89 • Number of events 2 • 8 weeks
|
2.2%
2/93 • Number of events 2 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal Cramping
|
1.1%
1/89 • Number of events 1 • 8 weeks
|
2.2%
2/93 • Number of events 2 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/89 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Acute Gastroenteritis
|
1.1%
1/89 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Gastrointestinal disorders
Decrease In The Frequency In Bm
|
0.00%
0/89 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/89 • Number of events 1 • 8 weeks
|
3.2%
3/93 • Number of events 3 • 8 weeks
|
|
Gastrointestinal disorders
Extreme Lower Abdominal Pain
|
0.00%
0/89 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Rectal Bleeding
|
1.1%
1/89 • Number of events 1 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Uncomfortable Bm
|
0.00%
0/89 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Viral Gastroenteritis
|
0.00%
0/89 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89 • 8 weeks
|
2.2%
2/93 • Number of events 2 • 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