Long term efficacy of Lubiprostone for paed. functional constipation
Research type
Research Study
Full title
A Multicentre, Long-term Safety, Efficacy and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥6 to <18 years with Functional Constipation
IRAS ID
153453
Contact name
Nikhil Thapar
Contact email
Sponsor organisation
Sucampo AG
Eudract number
2013-004384-31
Duration of Study in the UK
2 years, 9 months, days
Research summary
This is a phase 3, multicentre, long term study to assess the safety, efficacy, and
pharmacokinetics of oral lubiprostone for the treatment of functional constipation in children. Approximately 300 subjects who participated in the preceding, double-blinded study(SAG/0211PFC-1131) will be enrolled in the study across approximately 100 sites within the United States, Canada, and Europe. Dose assignment will be based on the dose they were receiving at the time of rolling over 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 (as identified via IXRS), assignment of dose by the IXRS will be based on subject body weight at the time of rollover to this extension study. Dose assignment will only be known in subjects who were at least 50 kg in weight at the time of randomisation in the preceding study (SAG/0211PFC-1131). All dose assignments will be handled by the IXRS and will continue to maintain blinding with respect to the treatment assignment in the preceding trial. Duration of subject participation is approximately 42 weeks
through follow up.REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/0816
Date of REC Opinion
25 Jul 2014
REC opinion
Further Information Favourable Opinion