A Multicentre, Long-term Safety, Efficacy and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged *6 to <18 years with Functional Constipatio

Phase 3

Completed

• Conditions: constipation in children and adolescents; functional constipation; 10017977

• Registration Number: NL-OMON41677
• Lead Sponsor: Sucampo AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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.

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, refuses/unwilling to undergo pregnancy testing, and/or 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
• Study Design: Not specified