NCT04458675

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

A Prospective, Multicenter, Randomized, Single Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.

Detailed description

Visit 1 -Screening: Subjects will be screened to the study at the screening visit, PAC-QOL questionnaire will be completed and subject will have a run-in time for a period of 2-3 weeks, assuring 14 consecutive days of eDiary with an average of \< 3 SBM per week. Visit 2 - Baseline: After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be randomized to either Vibrant or Vibrant placebo for a treatment period of 8 weeks. Subjects, in both arms, will have their first administration of Vibrant capsule / Vibrant placebo on site at the day of baseline visit and will be instructed on their treatment administration at home and will be requested to ingest the capsules at a specific time of the day. At baseline, subjects will also be trained on how to use the base unit at home. Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study (including the run-in period). The eDiary will include questions on: * Daily BM, SBM, CSBM * Change of their diet, if applicable (NOTE: the protocol will not ask/require the subjects to change anything in his/her diet) * Change in sympotms as: brisol stool consistancy, straining, bloating, and the other questions in the eDiary * Medication * AE (including diarhrea) The first 2 weeks of treatment will be considered as a subjects' training period. Visit 3 -after 4 weeks of treatment - an on site visit will take place to evaluate subject's safety and treatment efficacy and additional capsule dispencing. Visit 4 Final visit -after another 4 weeks of treatment - an on site visit will take place to evaluate subject's safety and treatment efficacy and collect the base unites and remaning capsules. PAC-QOL, Ease of use and TSQM questionnaires will be completed. During the entire study period, data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period. Subjects will receive phone calls at least once a week and subject compliance will be monitored throughout the 8 weeks of the study. Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement. Data about time of activation of the capsules will be automatically registered and transmitted by the base unit for Vibrant capsules

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DEVICE	Vibrant capsule	The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility
DRUG	Placebo	A biodegradable capsule, which visually similar to the Vibrant active capsule

Timeline

• Start date: 2018-07-26
• Primary completion: 2019-01-07
• Completion: 2019-03-30
• First posted: 2020-07-07
• Last updated: 2024-06-14
• Results posted: 2024-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study