Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorValenta Pharm JSC
About this trial
The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged 18-70 years.
Diagnosed with chronic cholecystitis (K81.1) and/or dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and/or imaging/laboratory findings.
Upper abdominal pain or discomfort attributable to gallbladder or biliary tract dysfunction (per investigator assessment), accompanied by ≥1 of the following: heartburn, belching, nausea, abdominal bloating, borborygmi (stomach rumbling), flatulence, constipation, or diarrhea.
Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
Disqualifiers
Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
Lack of Efficacy. Study treatment will be discontinued if no clinical improvement is observed by Visit 3 (Day 15 ± 1), defined as persistence or worsening of upper abdominal pain/discomfort (assessed by Visual Analog Scale [VAS]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.
Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
Requirement for prohibited concomitant therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
4-MUST
Drug128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Placebo
DrugPlacebo tablet.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: 4-MUSTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 29 ± 1Secondary outcomes
1
Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 2 - Day 282
Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more) by days 8, 15, 22, and 29 following treatment initiation.
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 13
Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more) by days 8, 15, 22, and 29 following treatment initiation.
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 14
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 29 ± 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov