A prospective, exploratory, parallel-group, low-intervention, phase IV, randomized, double-blind, placebo-controlled, multi-center, national, 2-arm trial to investigate efficacy and safety of Amara-Tropfen (Amara drops) in patients with irritable bowel syndrome (IBS)

Irritable Bowel Syndrome

1. Change in intensity of gastrointestinal discomfort using the weekly mean of a visual analogue scale (VAS value: 0-100 mm; 0=no discomfort, 100=most intense discomfort) after randomization until the end of the treatment period (treatment week 1, …, treatment week 8) and the baseline value (=mean of at least 4 VAS values documented on 7 days prior to randomization) in comparison of verum and placebo.

2. Change in IBS-SSS total score (range: 0 to 500; scores between 0–74 are considered `no to minimal IBS symptoms´, scores between 75–174 are considered `mild IBS´, 175–299 `moderate IBS´, >300 `severe IBS´) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 2a. Change in IBS-SSS single score `abdomen or belly pain´ (range: 0 to 100) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 2b. Change in IBS-SSS single score `number of days with abdominal pain every 10 days (number of days with pain)´ (range: 0 to 100) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 2c. Change in IBS-SSS single score `abdominal distension/tightness´ (range: 0 to 100) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 2d. Change in IBS-SSS single score `satisfaction with bowel habits´ (range: 0 to 100) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 2e. Change in IBS-SSS single score `affecting/interfering of irritable bowel syndrome with life in general´ (range: 0 to 100) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 3. Change in total score (range: 34 to 170) of the irritable bowel syndrome specific quality of life questionnaire (IBS-QOL with 34 questions, Patrick et al., 1998) between visit 4 and baseline in comparison of verum and placebo., 4. Proportion of patients showing significant decrease in symptoms (= responder (yes/no)) at visit 3, visit 4, visit 5 (with visit 3 and visit 4, visit 5 considered separately) in comparison of verum and placebo. (Note: A responder is defined as a patient with ≥ 50 points decrease in IBS-SSS total score at visit 3, visit 4, visit 5 compared to baseline, with visit 3, visit 4, visit 5 considered separately.), 5. Change in PAGI-SYM mean total score (range: 0 to 5; calculated as the mean of the 20 items (symptoms), with each item (symptom) rated on a six-point scale: 0=none to 5=very severe) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 5a. Change in PAGI-SYM mean subscale score `heartburn/ regurgitation´ (range: 0 to 5) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 5b. Change in PAGI-SYM mean subscale score `nausea/ vomiting´ (range: 0 to 5) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 5c. Change in PAGI-SYM mean subscale score `post-prandial fullness/early satiety´ (range: 0 to 5) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 5d. Change in PAGI-SYM mean subscale score `bloating´ (range: 0 to 5) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo, 5e. Change in PAGI-SYM mean subscale score `upper abdominal pain´ (range: 0 to 5) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 5f. Change in PAGI-SYM mean subscale score `lower abdominal pain´ (range: 0 to 5) between visit 3, visit 4, visit 5 and baseline (with visit 3, visit 4 and visit 5 considered separately) in comparison of verum and placebo., 6. Proportion of patients who discontinue the trial due to lack of efficacy (yes/no) at visit 3, visit 4 (with visit 3 and visit 4 considered separately) in comparison of verum and placebo., 7. Proportion of patients who rate efficacy of IMP (very good, good, neither good nor bad, bad, very bad) at visit 4 in comparison of verum and placebo., 8. Proportion of patients for whom the investigator rates efficacy of IMP (very good, good, neither good nor bad, bad, very bad) at visit 4 in comparison of verum and placebo., 9. Proportion of patients who would continue the treatment with IMP (yes/no) at visit 4 in comparison of verum and placebo., 10. Number, nature (term), causality, severity and seriousness of Adverse Events (AEs) in comparison of verum and placebo., 11. Proportion of patients who discontinue the trial due to an adverse event in comparison of verum and placebo., 12. Proportion of patients who rate safety of IMP (very good, good, neither good nor bad, bad, very bad) at visit 4 or the end of the trial in case of premature end of study in comparison of verum and placebo., 13. Proportion of patients for whom the investigator rates safety of IMP (very good, good, neither good nor bad, bad, very bad) at visit 4 or the end of the trial in case of premature end of study in comparison of verum and placebo

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