Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia

Conditions

Functional Dyspepsia

Brief summary

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.

Detailed description

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.

Related papers

No related papers found yet.

Interventions

DRUGThe placebo has the same composition as the investigational medicinal product alkacitrat effervescent tablet 2 g/tab (with the exception of the active substance)

DRUGis manufactured by the same manufacturer (uni-pharma kleon tsetis pharmaceutical laboratory s.a) and is not sterile.

DRUGALKACITRAT Αναβράζον δισκίο 2 g/tab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Greece

Outcome results

None listed