Trial Outcomes & Findings for A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes (NCT NCT03329027)
NCT ID: NCT03329027
Last Updated: 2024-07-03
Results Overview
CSBM1 success rate, defined as an increase from the base line 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
67 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Vibrant Active Mode 1
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Vibrant Active Mode 2
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
24
|
|
Overall Study
COMPLETED
|
11
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
8
|
Reasons for withdrawal
| Measure |
Vibrant Active Mode 1
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Vibrant Active Mode 2
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
9
|
5
|
7
|
Baseline Characteristics
A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes
Baseline characteristics by cohort
| Measure |
Vibrant Active Mode 1
n=21 Participants
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Vibrant Active Mode 2
n=22 Participants
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham
n=24 Participants
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
44.39 years
n=39 Participants
|
41.85 years
n=41 Participants
|
41.31 years
n=35 Participants
|
42.51 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
57 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native American or American Indian
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian/ Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
67 Participants
n=31 Participants
|
|
Duration of constipation
|
14.86 years
n=39 Participants
|
8.45 years
n=41 Participants
|
11.15 years
n=35 Participants
|
11.48 years
n=31 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Analysis of 44 subjects who completed at least 6 weeks of treatment
CSBM1 success rate, defined as an increase from the base line of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
Outcome measures
| Measure |
Active Comparator-Vibrating Mode 1
n=11 Participants
Patients will receive vibrating capsule Vibrating Mode 1 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Active Comparator-Vibrating Mode 2
n=17 Participants
Patients will receive vibrating capsule Vibrating Mode 2 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham Comparator
n=16 Participants
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week). The Sham capsule is visually similar to the active capsules (Active Mode 1 and Active Mode 2, which differ in their vibration sessions) but without the active components.
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
|---|---|---|---|
|
CSBM1- an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
|
7 Participants
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 6-8 weeksPopulation: Analysis of 44 subjects who completed at least 6 weeks of treatment
CSBM2 success rate, defined as an increase from the base line of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.
Outcome measures
| Measure |
Active Comparator-Vibrating Mode 1
n=11 Participants
Patients will receive vibrating capsule Vibrating Mode 1 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Active Comparator-Vibrating Mode 2
n=17 Participants
Patients will receive vibrating capsule Vibrating Mode 2 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham Comparator
n=16 Participants
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week). The Sham capsule is visually similar to the active capsules (Active Mode 1 and Active Mode 2, which differ in their vibration sessions) but without the active components.
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
|---|---|---|---|
|
CSBM2- an Increase of at Least Two Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
|
2 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6-8 weeksPopulation: Analysis of 44 subjects who completed at least 6 weeks of treatment
SBM success rate, defined as as an increase from the base line of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 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.
Outcome measures
| Measure |
Active Comparator-Vibrating Mode 1
n=11 Participants
Patients will receive vibrating capsule Vibrating Mode 1 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Active Comparator-Vibrating Mode 2
n=17 Participants
Patients will receive vibrating capsule Vibrating Mode 2 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham Comparator
n=16 Participants
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week). The Sham capsule is visually similar to the active capsules (Active Mode 1 and Active Mode 2, which differ in their vibration sessions) but without the active components.
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
|---|---|---|---|
|
SBM 1- Success Rate, Defined as as an Increase From the Base Line of at Least One Weekly Spontaneous Bowel Movement (SBM) During at Least 6 of the 8 Weeks of Treatment.
|
8 Participants
|
9 Participants
|
7 Participants
|
Adverse Events
Vibrant Active Mode 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vibrant Active Mode 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vibrant Active Mode 1
n=21 participants at risk
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Vibrant Active Mode 2
n=22 participants at risk
Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Vibrating Capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
Sham
n=24 participants at risk
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)
Sham capsule: Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/discomfort
|
4.8%
1/21 • For each patient, safety data was collected for 10 weeks of study participation.
|
9.1%
2/22 • For each patient, safety data was collected for 10 weeks of study participation.
|
0.00%
0/24 • For each patient, safety data was collected for 10 weeks of study participation.
|
|
Gastrointestinal disorders
Abdominal distention/Bloating and/or Flatulence
|
9.5%
2/21 • For each patient, safety data was collected for 10 weeks of study participation.
|
4.5%
1/22 • For each patient, safety data was collected for 10 weeks of study participation.
|
0.00%
0/24 • For each patient, safety data was collected for 10 weeks of study participation.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • For each patient, safety data was collected for 10 weeks of study participation.
|
4.5%
1/22 • For each patient, safety data was collected for 10 weeks of study participation.
|
4.2%
1/24 • For each patient, safety data was collected for 10 weeks of study participation.
|
|
Product Issues
Sensation of vibration
|
4.8%
1/21 • For each patient, safety data was collected for 10 weeks of study participation.
|
9.1%
2/22 • For each patient, safety data was collected for 10 weeks of study participation.
|
12.5%
3/24 • For each patient, safety data was collected for 10 weeks of study participation.
|
|
Renal and urinary disorders
UTI
|
0.00%
0/21 • For each patient, safety data was collected for 10 weeks of study participation.
|
4.5%
1/22 • For each patient, safety data was collected for 10 weeks of study participation.
|
0.00%
0/24 • For each patient, safety data was collected for 10 weeks of study participation.
|
|
General disorders
Headache
|
4.8%
1/21 • For each patient, safety data was collected for 10 weeks of study participation.
|
13.6%
3/22 • For each patient, safety data was collected for 10 weeks of study participation.
|
4.2%
1/24 • For each patient, safety data was collected for 10 weeks of study participation.
|
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