Trial Outcomes & Findings for Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (NCT NCT03879239)
NCT ID: NCT03879239
Last Updated: 2024-08-09
Results Overview
CSBM1Success Rate: defined as the number of subjects 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. CSBM2 success rate: defined as the number of subject 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. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis (Vibrant Capsule Mode A), than in the placebo arm 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
349 participants
8 weeks of treatment
2024-08-09
Participant Flow
The study was conducted at 95 centers in the USA. Recruitment began on 8 Apr 2019 and concluded on 16 July 2021.
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 |
Vibrant Capsule Mode A
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Vibrant Capsule Mode B
Vibrant Capsule mode B administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
Placebo Capsule administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
|---|---|---|---|
|
Overall Study
STARTED
|
163
|
37
|
149
|
|
Overall Study
COMPLETED
|
141
|
30
|
133
|
|
Overall Study
NOT COMPLETED
|
22
|
7
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
Vibrant Capsule Mode A
n=163 Participants
Vibrant Capsule mode A administered 5 times per week.
|
Vibrant Capsule Mode B
n=37 Participants
Vibrant Capsule mode B administered 5 times per week. Based on the analysis of the first pre-define phase of the study Arm B was discontinued.
|
Placebo Capsule
n=149 Participants
Placebo Capsule administered 5 times per week.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
45 years
STANDARD_DEVIATION 12.25 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 13.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
77 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
31 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
41 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/ Pacific Islander
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Duration of constipation (years)
|
17.90 years
STANDARD_DEVIATION 14.15 • n=5 Participants
|
11.20 years
STANDARD_DEVIATION 10.00 • n=7 Participants
|
14.50 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
15.80 years
STANDARD_DEVIATION 13.17 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeks of treatmentPopulation: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.
CSBM1Success Rate: defined as the number of subjects 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. CSBM2 success rate: defined as the number of subject 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. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis (Vibrant Capsule Mode A), than in the placebo arm 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 |
Vibrant Capsule Mode A
n=163 Participants
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
n=149 Participants
Placebo Capsule administered 5 times per week
|
|---|---|---|
|
CSBM1 & CSBM2 Success Rate
CSBM1 Success Rate
|
64 Participants
|
33 Participants
|
|
CSBM1 & CSBM2 Success Rate
CSBM2 Success Rate
|
37 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 8 weeks of treatmentPopulation: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.
Change from baseline in average straining using (0-10) scale where "0" is no straining and "10" is unbearable straining
Outcome measures
| Measure |
Vibrant Capsule Mode A
n=163 Participants
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
n=149 Participants
Placebo Capsule administered 5 times per week
|
|---|---|---|
|
Change From Baseline in Average Straining
|
-1.56 units on a scale
Interval -1.9 to -1.22
|
-1.0 units on a scale
Interval -1.4 to -0.6
|
SECONDARY outcome
Timeframe: 8 weeks of treatmentPopulation: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.
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 |
Vibrant Capsule Mode A
n=163 Participants
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
n=149 Participants
Placebo Capsule administered 5 times per week
|
|---|---|---|
|
Change From Baseline in Average Stool Consistency
|
0.92 units on a scale
Interval 0.75 to 1.09
|
0.44 units on a scale
Interval 0.24 to 0.64
|
SECONDARY outcome
Timeframe: 8 weeks of treatmentPopulation: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.
Change from baseline in average bloating using scale (0-10) for bloating where 0=No bloating and 10=Unbearable bloating
Outcome measures
| Measure |
Vibrant Capsule Mode A
n=163 Participants
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
n=149 Participants
Placebo Capsule administered 5 times per week
|
|---|---|---|
|
Change From Baseline in Average Bloating
|
-0.33 units on a scale
Interval -0.59 to -0.08
|
-0.23 units on a scale
Interval -0.53 to 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks of treatmentPopulation: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.
Change from baseline in weekly number of Spontaneous Bowel Movement (SBM)
Outcome measures
| Measure |
Vibrant Capsule Mode A
n=163 Participants
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
n=149 Participants
Placebo Capsule administered 5 times per week
|
|---|---|---|
|
Change in SBM
|
1.4 bowel movements/week
Interval 1.08 to 1.73
|
1.24 bowel movements/week
Interval 0.87 to 1.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks of treatmentPopulation: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.
Change from baseline in average PAC-QOL (=Patient Assessment of Constipation Quality of Life) score. The results below present the number of participants who completed PAC-QOL questionnaire and reported an improvement in quality of life from baseline.
Outcome measures
| Measure |
Vibrant Capsule Mode A
n=145 Participants
Vibrant Capsule mode A administered 5 times per week
Vibrating capsule: Vibrating Capsule administered 5 times per week
|
Placebo Capsule
n=136 Participants
Placebo Capsule administered 5 times per week
|
|---|---|---|
|
Change From Baseline in Quality of Life
|
113 Participants
|
90 Participants
|
Adverse Events
Vibrant Capsule Mode A
Vibrant Capsule Mode B
Placebo Capsule
Serious adverse events
| Measure |
Vibrant Capsule Mode A
n=163 participants at risk
Vibrant Capsule mode A administered 5 times per week
|
Vibrant Capsule Mode B
n=37 participants at risk
Vibrating capsule mode B administered 5 times per week. Based on the predefined interim analysis, mode B was discontinued, and the trial was completed using mode A. Therefore, only safety data was available for the dropped Arm B.
|
Placebo Capsule
n=149 participants at risk
Placebo Capsule administered 5 times per week
|
|---|---|---|---|
|
Gastrointestinal disorders
significant abdominal pain
|
0.00%
0/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.67%
1/149 • Number of events 1 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Nervous system disorders
transient ischemic attack
|
0.00%
0/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.67%
1/149 • Number of events 1 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
Other adverse events
| Measure |
Vibrant Capsule Mode A
n=163 participants at risk
Vibrant Capsule mode A administered 5 times per week
|
Vibrant Capsule Mode B
n=37 participants at risk
Vibrating capsule mode B administered 5 times per week. Based on the predefined interim analysis, mode B was discontinued, and the trial was completed using mode A. Therefore, only safety data was available for the dropped Arm B.
|
Placebo Capsule
n=149 participants at risk
Placebo Capsule administered 5 times per week
|
|---|---|---|---|
|
Product Issues
Sensation of vibration
|
11.0%
18/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.7%
1/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Nervous system disorders
Headache
|
1.8%
3/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.7%
1/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.7%
4/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Renal and urinary disorders
Urinary tract infection
|
1.8%
3/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.7%
1/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.3%
2/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.7%
1/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
4.7%
7/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
2/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
5.4%
2/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.67%
1/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.67%
1/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Abdominal distention
|
0.61%
1/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.3%
2/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Anorectal problem
|
0.61%
1/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.7%
4/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
2/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Infections and infestations
Covid-19
|
0.61%
1/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
1.3%
2/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis/ Bronchitis
|
1.8%
3/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
5.4%
2/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
2.0%
3/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.2%
2/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.67%
1/149 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
|
General disorders
Fatigue
|
1.2%
2/163 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
5.4%
2/37 • The Safety reporting conducted throughout the treatment period (8 weeks)
|
0.00%
0/149 • 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