SYFbcdfa8909ef84abc865ba24a3ac3214aRegistry ID: 2024-512688-30-00|RecruitingPhase 4
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interventional
N/A
1 country
1
Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2024
Actual (reported)Comparison of the percentage of patients with improvement (ΔGOS ≥2) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
Comparison of the percentage of patients who responded to treatment (GOS score ≤2 at visit V1) between treatment groups
Comparison of the change in patients' quality of life based on the NDI-SF index at visit V1 versus baseline visit (V0) between the two treatment groups.
Comparison of the change in severity of each symptom (VAS scale) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
Comparison of the percentage of patients in whom there was a decrease in GOS scale score of at least one point at visit V1 compared to the baseline visit (V0) between the two treatment groups.
Frequency and type of adverse events during the study.
Contact the study team to confirm eligibility.
University General Hospital Of Thessaloniki Ahepa
Thessaloniki, 546 36, Greece
Uni-pharma SA
First Submitted
March 22, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia