Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04458675
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2020-06-09
Brief Title:
Efficacy and Safety of Vibrant Capsule vs Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation CIC
Sponsor:
Vibrant Ltd
Organization:
Vibrant Ltd
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIC
Brief 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 askrequire the subjects to change anything in hisher 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 subjects 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 subjects 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
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 askrequire the subjects to change anything in hisher 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 subjects 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None