ong-term safety extension study of lubiprostone for the treatment of paediatric functional constipation in subjects aged =6 to <18 years

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 418

Inclusion Criteria

1.Written informed consent obtained from subject and/or parent/legal guardian (and assent from subject where applicable).
2.Subject must have completed the entire 12-week treatment period from the preceding study (SAG/0211PFC-1131) prior to enrolment.
3.Subject must continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility; these medications include:
a.Cholinesterase inhibitors; anti-spasmodic, anti-diarrheal, anti-constipation, or prokinetic agents; laxative agents (e.g., PEG 3350), including homeopathic remedies;
b.Tricyclic antidepressants; or
c.Any medication, at the discretion of the Investigator, known to cause constipation or constipation-related symptoms.
Exceptions: Treatment with anticholinergic agents, SSRIs, SNRIs, or MAO inhibitors is allowed if a stable dose has been used for at least 30 days prior to the Baseline Visit (of the preceding study SAG/0211PFC-1131) and not likely to change during the study.
4.Subject (and if necessary, parent/legal guardian) must be willing and able to use or administer recommended (rectal and/or oral) rescue medications if needed.
5.If subject is taking a fibre supplement (e.g., Metamucil®, PerDiem®, Fybogel), usage must have been at a stable dose not likely to change during the study.
6.Subject and his/her parent/legal guardian must be willing and able to fill out his/her own diary

Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject has current evidence of untreated faecal impaction.
2.Subject has experienced an adverse event during the SAG/0211PFC-1131 study which the Investigator considers to be clinically significant and would limit the subject’s ability to participate in the trial.
3.Subject has had a significant change in their medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease, which the Investigator considers to be clinically significant and would limit the subject’s ability to participate in the trial.
4.Subject has developed abnormal laboratory test (haematology, urinalysis, or blood chemistry), which in the Investigator’s opinion is clinically significant, unexplained, and would limit the subject’s ability to participate in the trial.
5.Subject (female of childbearing potential) has a positive pregnancy test or refuses/is unwilling to undergo pregnancy testing, and/ does not agree to use protocol-specified contraceptive measures for the duration of the study.
6.Subject demonstrated non-compliance with study protocol (i.e., dosing schedule, visit schedule, diary completion, or study procedures) during the SAG/0211PFC-1131 study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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