Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT01674166
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a confirmed diagnosis of FFR, defined as a minimum 2-month history of faecal impaction, plus at least one of the following:
* \< 3 bowel movements per week at the toilet;
* A history of soiling;
* Male and female subjects ≥ 4 to ≤ 12 years of age, with a Tanner stage 1 of 2 or less;
* Weight-height proportionality for age within the 5th and 95th percentile;
* Written informed consent, signed by the subject's legal guardian and by the investigator, and;
* Subject assent documented in the form of a note-to-file in the subject's source documentation.
Exclusion Criteria:
* Requirement for any medication during the period of the trial;
* Evidence by examination or laboratory tests of abnormal growth;
* An abnormal neurologic examination;
* Cystic fibrosis;
* History of, or current anorectal malformations;
* Diagnosed chromosomal abnormalities (e.g., Down's Syndrome);
* Disease state or surgery known to significantly affect the gastrointestinal absorption of drugs, or the assessment of the trial drug's effect;
* Any history, clinical and/or biochemical evidence of clinically significant renal or liver disease or cirrhosis;
* Clinically significant anaemia;
* Use of any investigational drug within the 4-week period prior to administration of trial medication.
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT01674166
Study Brief:
Protocol Section:
NCT01674166