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Trial Outcomes & Findings for Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration (NCT NCT02829047)

NCT ID: NCT02829047

Last Updated: 2024-06-14

Results Overview

Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

6 weeks of treatment

Results posted on

2024-06-14

Participant Flow

Participant milestones

Participant milestones
Measure
Vibrating Capsule
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) Vibrating Capsule: Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Overall Study
STARTED
25
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Vibrating Capsule
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) Vibrating Capsule: Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vibrating Capsule
n=25 Participants
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) Vibrating Capsule: Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Age, Continuous
44.9 years
STANDARD_DEVIATION 12.52 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
Race/Ethnicity, Customized
Cacucasian
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
21 Participants
n=5 Participants
Race/Ethnicity, Customized
Native American or American Indian
1 Participants
n=5 Participants
Region of Enrollment
United States
25 participants
n=5 Participants
Duration of constipation (years)
12.2 years
STANDARD_DEVIATION 11.18 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks of treatment

Population: subjects with an improvement of at least 1 SBM a week, 3 out of 6 weeks

Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 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

Outcome measures
Measure
Vibrating Capsule
n=24 Participants
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) Vibrating Capsule: Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Spontaneous Bowel Movements Success Rate
21 Participants

Adverse Events

Vibrating Capsule

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Vibrating Capsule
n=25 participants at risk
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) Vibrating Capsule: Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
Gastrointestinal disorders
Abdominal pain
4.0%
1/25 • For each patient, safety data was collected for 8 weeks of study participation.
Gastrointestinal disorders
Nausea
4.0%
1/25 • For each patient, safety data was collected for 8 weeks of study participation.
Gastrointestinal disorders
Emesis
4.0%
1/25 • For each patient, safety data was collected for 8 weeks of study participation.
Renal and urinary disorders
exacerbation of kidney stones
4.0%
1/25 • For each patient, safety data was collected for 8 weeks of study participation.

Additional Information

Clinical trials manager

Vibrant Gastro

Phone: 046663322

Results disclosure agreements

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

Restriction type: OTHER