A Trial to Evaluate the Efficacy and Safety of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alfasigma S.p.A.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Male and female patients aged from 2 to less than 18 years during the entire study period undergoing elective colonoscopy;

2. Female subjects currently either of:

• Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is surgically sterilised via documented hysterectomy or bilateral tubal ligation), or

• Childbearing potential: the subject is eligible to enter and participate in this study if she is not lactating and has a negative pregnancy test, and agrees to abstain from intercourses until the colonoscopy is performed (only menstruated females);

3. Patients whose parents/legal representatives have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent;

4. Children aged from 6 to less than 12 years providing informed assent whenever possible;

5. Adolescents aged from 12 to less than 18 years providing informed assent;

6. Ability of the subjects and/or their parents/legal representatives to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

1. Requirement for urgent colonoscopy;

2. Gastrointestinal obstruction or perforation;

3. Bowel pseudo-obstruction;

4. Gastric retention;

5. Toxic colitis;

6. Toxic megacolon;

7. Known or suspected hypersensitivity to the active or other ingredients of both test product and reference product;

8. Clinically significant electrolyte imbalance;

9. Prior intestinal resection;

10. Structural abnormality of the lower gastrointestinal (GI) tract;

11. Known metabolic (particularly phenylketonuria), hepatic, renal or cardiac disease;

12. Congestive heart failure (NYHA class III and IV);

13. Known pregnancy;

14. Subject who have participated in another clinical trial or have taken an investigational drug within the last 3 months prior screening.