Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in improving the overall symptom severity of functional dyspesia and/or heartburn
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
1.55g chewable tablet 5 times a day for 2 weeks
1.55 g chewable tablet 5 times a day for 2 weeks
CS Albuñol
Albuñol, Spain
CS Disset de Setembre
el Prat de Llobregat, Spain
CS Montesa
Madrid, Spain
CS Goya
Madrid, Spain
Change in overall symptom severity from baseline (day 0) to day 14 between the two study arms
The primary endpoint is the change in the score of a visual analog scale (VAS) (from "no symptoms" to "overwhelming symptoms") used for evaluating overall symptom severity from baseline (day 0) to day 14 after treatment initiation, between the two study arms. A decrease in VAS score of at least 30% is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease ≥30% in this scale will be considered as responders. The non-inferiority is considered demonstrated if the 95% confidence interval of the difference in the percentage of responders between both study arms lies within the non-inferior margin value defined of 20%.
Time frame: Day 0 and Day 14
Responders from baseline to day 3 and day 7
Percentage of responder patients (VAS score decrease of at least 30%) on the basis of the mean change in the overall symptom severity assessed by the VAS score from baseline to day 3 and day 7 in both study arms
Time frame: Day 0, Day 3 and Day 7
Self-assessment severity of individual specific symtoms
Comparison between Mipolixin® and Poliprotect® in the mean change of the score of the self-assessed severity of individual specific symtoms (bothersome postprandial fullness, bothersome early satiation, bothersome epigastric pain, bothersome epigastric burning, and bothersome heartburn) rated on a 100 mm VAS (from "no symptoms" to "overwhelming symptoms") from baseline to 1 3, 7 and 14 days after treatment initiation.
Time frame: Day 0, Day 1, Day 3, Day 7 and Day 14
Change in the score of GOS scale from baseline to day 1
Change in the score of GOS ( Global Overall Symptom) scale from baseline to day 14 in both study arms. A decrease in GOS score ≥2 is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease in overall severity score ≥2 from baseline in this scale will be considered as responders.
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Primary Care Centre Eloy Gonzalo
Madrid, Spain
CS Comillas
Madrid, Spain
CS Baviera
Madrid, Spain
CS Las Americas
Parla, Spain
CS San Blas
Parla, Spain
CS Isabel II
Parla, Spain
...and 1 more locations
Time frame: Day 0 and Day 14
Incidence of AEs during study treatment
Incidence and type of adverse events (AEs) and serious adverse events (SAEs) reported during study treatment.
Time frame: Day 0 to Day 14
Incidence of AEs and clinical findings during study period
Safety will be assessed on the basis of all AEs experienced during study treatment and all observed and volunteered AEs and abnormal findings on physical examination, including vital signs throughout the study.
Time frame: Day 0 to Day 28
Patient satisfaction (treatment administration)
Patient level of satisfaction in terms of treatment administration/posology will be assessed by means of specific questions about patient level of satisfaction after the 2-week treatment period. The response will be scored on a 4-point Likert scale from 0 to 4, as follows: 1 = "very satisfied", 2 = "quite satisfied", 3 = "somewhat satisfied", 4 = "not satisfied".
Time frame: Day 3, Day 7 and Day 14
Patient satisfaction (taste)
Patient level of satisfaction in terms of chewable tablets taste will be assessed by means of specific questions about patient level of satisfaction after the 2-week treatment period. The response will be scored on a 4-point Likert scale from 0 to 4, as follows: 1 = "very satisfied", 2 = "quite satisfied", 3 = "somewhat satisfied", 4 = "not satisfied".
Time frame: Day 3, Day 7 and Day 14
Treatment compliance
Treatment compliance will be evaluated by performing the IP accountability. This data will be corroborated with the information recorded in the patient diary concerning the daily administered and missed doses.
Time frame: Day 0 to Day 14