Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or epigastric pain
Comparison of heartburn or epigastric pain severity following administration of Neobianacid® (Group B) or omeprazole (Group A) from day 0 to day 27. An ad-hoc placebo will be also administered in both treatment arms. Then, a following phase (day 28-55) will follows in which Neobianacid® will be administered (on demand) to both treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
275
Oral administrations of Neobianacid® (30' after meals and on demand)
Daily administration Omeprazole 20mg (per os, 30' before breakfast).
Oral administrations of Neobianacid® placebo (30' after meals and on demand)
Azienda Ospedaliera Santa Maria Goretti
Latina, Rome, Italy
Ospedale Civile San Salvatore
L’Aquila, Italy
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, Italy
Heartburn or epigastric pain severity through treatment (Day-1 to Day13)
Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms"); from Baseline to Day 13, between groups. Baseline is defined as Day -1
Time frame: Day-1 to Day13
Heartburn or epigastric pain severity through treatment (Day-1 to Day7)
Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms") from Baseline to Day 1, Day 3 and Day 7, between groups
Time frame: Day-1 to Day7
Heartburn or epigastric pain severity through treatment (Day14 to Day27)
Assessment of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms"); from Day 14 to Day 27 between groups.
Time frame: Day14 to Day27
Assessment of of rescue medication use
Assessment of use (starting date and quantity) of rescue medication (antacid); from Baseline to Day 13, from Day 14 to Day 27 and from Day 28 to Day 55, between groups.
Time frame: Day-1 to Day55
Tablets of Neobianacid® Vs. Neobianacid® placebo Day14 to Day27
Assessment of number of tablets of Neobianacid® on demand in comparison to Neobianacid® placebo on demand; from Day 14 to Day 27, between groups.
Time frame: Day14 to Day27
Tablets of Neobianacid® Vs. Neobianacid® placebo Day28 to Day55
Assessment of number of tablets of Neobianacid® on demand; from Day 28 to Day 55, between groups.
Time frame: Day28 to Day55
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Daily administration Omeprazole placebo (per os, 30' before breakfast).
Azienda Ospedaliera Perugia
Perugia, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Italy
Ospedale San Giovanni Addolorata
Rome, Italy
Ospedale Sandro Pertini
Rome, Italy
Ospedale Sant'Eugenio
Rome, Italy
Policlinico Umberto I
Rome, Italy
Policlinico Universitario A. Gemelli
Rome, Italy
...and 2 more locations
Improvement in symptomatology
Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire - GSRS; Day 14, Day 28 and Day 56 versus Baseline, between groups.
Time frame: Day-1 to Day56
Improvement in quality of life
Improvement in quality of life, by means of Gastrointestinal Quality of Life Index - GIQLI questionnaire; Day 14, Day 28 and Day 56 versus Baseline, between groups.
Time frame: Day-1 to Day56
Evaluation of treatment
Evaluation of treatment by means of Overall Treatment Evaluation - OTE; Day 14, 28 and 56, between groups.
Time frame: Day-1 to Day56