Lubriprostone Extension 11S1

Principal Investigator: Molly  O'Gorman
Keywords: Lubiprostone , Sucampo , Constipation , Pediatric Department: Pediatric Administration
IRB Number: 00074110 Co Investigator:  
Specialty: Gastroenterology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Rachel Douglas
rachel.douglas@hsc.utah.edu
801-587-2570

Brief Summary

Primary Objective

To assess the long-term safety, efficacy, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) when administered orally for 36 weeks in paediatric subjects with functional constipation. Evaluation of lubiprostone safety is the primary objective in this study.

Dose assignment will be based on the dose they were receiving at the time of rolling over from the preceding, double-blind study (SAG/0211PFC-1131) into this safety extension study for those subjects who were randomised to receive lubiprostone during the preceding study. For subjects who received placebo during the preceding study, assignment of dose will be assigned based on subject body weight at the time of rollover to this extension study. All dose assignment will be handled by an Interactive Voice/Web Response system (IXRS) and will continue to maintain blinding with  respect to the treatment  assignment in the preceding trial.

Inclusion Criteria

  • Written informed consent obtained from subject or parent/legal guardian (and assent from subject where applicable).
  • Subject  must  have  completed  the  entire  12-week  treatment  period  during  the preceding study (SAG/0211PFC-1131).
  • Subject must continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility; these medications include:
    • Cholinesterase inhibitors; anti-spasmodic, anti-diarrheal, anti-constipation, or prokinetic agents; laxative agents (e.g., PEG 3350), including homeopathic remedies;
    • Tricyclic antidepressants; or
    • Any medication, at the discretion of the Investigator, known to relieve
      or cause constipation or constipation-related symptoms, and which the
      Investigator, based on the medical history of the subject, suspects to be a
      contributing factor to the patient’s chronic constipation, or may otherwise
      confound the evaluation of treatment response.

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.

  • 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.
  • 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.
  • Subject and his/her parent/legal guardian must be willing and able to fill out his/her own diary.

Exclusion Criteria

  • Subject has current evidence of untreated faecal impaction.
  • 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.
  • 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.
  • Subject has developed an abnormal laboratory test (haematology, urinalysis, or blood chemistry), which in the Investigator’s opinion is clinically significant and would limit the subject’s ability to participate in the trial.
  • Subject (female of childbearing potential) has a positive pregnancy test, refuses/is unwilling to undergo pregnancy testing, and/or does not agree to use protocol-specified contraceptive measures for the duration of the study.
  • Subject demonstrated non-compliance with study protocol (i.e., dosing schedule, visit schedule, diary completion, or study procedures) during the SAG/0211PFC-1131 study.