Lubiprostone for Children With Constipation
|ClinicalTrials.gov Identifier: NCT02138136|
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
This study is for children with constipation.
Children who completed 3 months of treatment in the earlier study (NCT02042183):
- were invited to participate
- will receive lubiprostone for 9 more months
- will see if lubiprostone safely relieves their constipation if taken for a whole year
|Condition or disease||Intervention/treatment||Phase|
|Constipation - Functional||Drug: Lubiprostone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation|
|Actual Study Start Date :||February 26, 2014|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||May 1, 2017|
Participants receive lubiprostone twice daily
Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study.
12 or 24 mcg soft capsules for oral administration
Other Name: Amitiza®
- Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month [ Time Frame: within 9 months ]Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
- Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs [ Time Frame: within 9 months ]Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.
- Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs [ Time Frame: within 9 months ]Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.
- Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain [ Time Frame: within 9 months ]Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138136
|Study Director:||Global Clinical Leader||Mallinckrodt|