Clinical Trial to Evaluate the Efficacy and Safety of MACRORANGE® in Patients Suffering from Constipation

Clinical Trial to Evaluate the Efficacy and Safety of MACRORANGE® in Patients Suffering from Functional Constipation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001914-13-BE

Enrollment

Registered

2018-08-01

Start date

2018-10-08

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation MedDRA version: 20.0 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Macrorange Pharmaceutical Form: Oral paste in sachet INN or Proposed INN: MACROGOL 4000 CAS Number: 25322-68-3 Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age of the patients: = 18 years of age; • Male and female patients; • Stool frequency =65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ; Secondary Objective: 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®. ; 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. ;Timepoint(s) of evaluation of this end point: Everyday during the 2-weeks treatment period (via a patient diary)	—

Measure

Time frame

Main Objective: 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. ; Secondary Objective: 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®. ; 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. ;Timepoint(s) of evaluation of this end point: Everyday during the 2-weeks treatment period (via a patient diary)

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Secondary

Measure	Time frame
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.; 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®.	—

Measure

Time frame

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.; 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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Countries

Belgium

Contacts

Public ContactFrédéric Segaud

Aepodia SA

regulatory@aepodia.com+32(0)10 39 20 11

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026