E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Constipation with stool frequency < 3 per week |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010774 |
E.1.2 | Term | Constipation |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of MACRORANGE® in patients with functional constipation (according to Rome III criteria) after daily administration of MACRORANGE® up to 14 days. |
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E.2.2 | Secondary objectives of the trial |
To describe the average daily dosage of MACRORANGE® from Day 3 up to End of Study. To further evaluate the tolerance of MACRORANGE® in patients with functional constipation. To evaluate the taste of MACRORANGE®.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age of the patients: ≥ 18 years of age; • Male and female patients; • Stool frequency < 3 per week; • Functional constipation as defined in constipation module of ROME III |
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E.4 | Principal exclusion criteria |
• Irritable Bowel Syndrome (IBS specifically type C); • Hypersensitivity to the active substances or any excipients; • Organic inflammatory bowel disease (ulcerative rectocolitis, Crohn’s disease); • Toxic megacolon; • Gastrointestinal obstruction or subocclusive syndromes; • Allergic to aspartame; • Painful abdominal syndromes of undetermined origin; • Existing partial colectomy or bariatric surgery (gastric bypass type); • Presumed non-cooperativeness; • Concomitant treatment from start of wash-out period until discharge from the study with any medication that may alter the gastrointestinal motility (see section 6.2.2) in the opinion of the Investigator; • Legal incapacity; • Any clinical condition which does not justify study participation in the Investigator's opinion; • Participation ≤ 8 weeks in a clinical trial; • Parallel participation in a clinical trial; • Repeated participation in this clinical trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
After a washout of one week, the primary endpoint will be: • The average number of complete spontaneous defecations per week for a 2 weeks period.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Everyday during the 2-weeks treatment period (via a patient diary) |
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E.5.2 | Secondary end point(s) |
Complete spontaneous defecations: • Change from baseline of the average number of complete spontaneous defecations per week for a 2 weeks period; • Average number of complete spontaneous defecations per week from Day 1 up to Day 7; • Average number of complete spontaneous defecations per week from Day 8 up to End of study.
Other endpoints: • Average of daily dosage of MACRORANGE® from Day 3 up to End of study; • Results of the constipation symptoms; • Results of the Clinical Global Impression (CGI, independent rater) as provided in Appendix 3; • Results of the Global assessment of efficacy (patient) in Appendix 3; • Assessment of safety parameters: adverse events, laboratory test results, ordinal scales regarding tolerability; • Taste of MACRORANGE®.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Everyday during the 2-weeks treatment period (via a patient diary) and/or during the study visits scheduled at Day 1, Day 8 and Day 15. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |