functional constipation in paediatric patients MedDRA version: 16.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Sucampo AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: throughout the entire 36 weeks treatment period (e-diary);Primary end point(s): The efficacy endpoints are as follows: • Overall and monthly changes from baseline in BM and SBM frequency rate • Overall and monthly assessments of the average degree of, and changes from baseline in: o Stool consistency of SBMs o Straining associated with SBMs o Abdominal pain associated with SBMs o Constipation severity • Monthly SBM Response o A monthly responder is defined as a subject who is a weekly responder for 3 of 4 weeks per month. o A weekly responder is defined as a subject who has a frequency rate of = 3 SBMs/week and an increase from baseline of = 1 SBM/week for that week. • Overall and monthly assessment of average treatment effectiveness rating • Overall Health-related quality of life (PedsQL™) • Overall and monthly change from baseline in incontinence episodes frequency (analysis performed for subset of subjects presenting with incontinence at baseline) • Overall and monthly change from baseline in the production of large diameter stool (a stool that clogs the toilet) frequency • Overall and monthly change from baseline in frequency of faecal impaction • Overall and monthly change from baseline in proportion of BMs and SBMs in toilet overall • Overall and monthly change from baseline in frequency of retentive posturing or excessive volitional stool retention The safety endpoints are as follows: • Incidence of adverse events grouped by MedDRA System Organ Class (SOC) and Preferred Term • Changes from baseline in clinical laboratory parameters (haematology, serum chemistry, urinalysis) • Changes from baseline in physical examination • Changes from basel | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactSenior Director Regulatory Affairs
Sucampo AG
Outcome results
None listed