Trial Outcomes & Findings for Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC) (NCT NCT04458675)

NCT ID: NCT04458675

Last Updated: 2024-06-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 59 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2024-06-14

Participant Flow

Participant milestones

Measure	Active Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility	Placebo Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule
Overall Study STARTED	31	28
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

Baseline characteristics by cohort

Measure	Active n=31 Participants Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility	Placebo n=28 Participants Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule	Total n=59 Participants Total of all reporting groups
Age, Continuous	45.91 years STANDARD_DEVIATION 11.87 • n=5 Participants	46 years STANDARD_DEVIATION 14.95 • n=7 Participants	46 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	28 participants n=7 Participants	59 participants n=5 Participants
Duration of constipation	18.06 years STANDARD_DEVIATION 13 • n=5 Participants	21.36 years STANDARD_DEVIATION 12.32 • n=7 Participants	19.62 years STANDARD_DEVIATION 12.70 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Active n=31 Participants Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility	Placebo n=28 Participants Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule
CSBM1 Success Rate	9 Participants	8 Participants

PRIMARY outcome

Timeframe: 8 weeks

The number of participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movements (CSBM) during at least 6 of the 8 weeks of treatment

Outcome measures

Measure	Active n=31 Participants Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility	Placebo n=28 Participants Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule
CSBM2 Success Rate:	7 Participants	5 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active n=31 participants at risk Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility	Placebo n=28 participants at risk Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule
Gastrointestinal disorders Diarrhea	3.2% 1/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	3.6% 1/28 • The Safety reporting conducted throughout the treatment period (8 weeks)
Gastrointestinal disorders Abdominal pain	3.2% 1/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	3.6% 1/28 • The Safety reporting conducted throughout the treatment period (8 weeks)
Gastrointestinal disorders Nausea	0.00% 0/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	3.6% 1/28 • The Safety reporting conducted throughout the treatment period (8 weeks)
Gastrointestinal disorders Vomiting	0.00% 0/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	3.6% 1/28 • The Safety reporting conducted throughout the treatment period (8 weeks)
Nervous system disorders Headache	3.2% 1/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	0.00% 0/28 • The Safety reporting conducted throughout the treatment period (8 weeks)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.2% 1/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	14.3% 4/28 • The Safety reporting conducted throughout the treatment period (8 weeks)
General disorders Other	6.5% 2/31 • The Safety reporting conducted throughout the treatment period (8 weeks)	0.00% 0/28 • The Safety reporting conducted throughout the treatment period (8 weeks)

Additional Information

Tal Malina / Clinical trials manager

Vibrant LTD

Phone: +972 046663322

Email: tal.m@vibrantgastro.com

Results disclosure agreements

• Principal investigator is a sponsor employee Permission to use study data is required
• Publication restrictions are in place

Restriction type: OTHER