Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403897
Status:
COMPLETED
Last Update Posted:
2008-04-16
First Post:
2006-11-24
Brief Title:
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
Sponsor:
Norgine
Organization:
Norgine
Study Overview
Official Title:
An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children
Detailed Description:
This was a phase III open single centre non-comparative study All patients were assigned to treatment with Movicol for a period of 12 weeks
All patients were screened at Day 0 Visit 1 when baseline assessment of their bowel movements over the previous 14 days were made Patients were dispensed with Movicol to commence treatment on the following day Day 1 During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved Thereafter until the end of the study the dosage was titrated according to the stool consistency diarrhoea loose stool hard stools or no bowel movement for 2 days respectively
Four on-treatment visits were performed on Day 14 Visit 2 Day 28 Visit 3 Day 56 Visit 4 and Day 84 Visit 5 At each visit bowel movements over the previous period were assessed by the investigator using the patients daily diary card data
All patients were screened at Day 0 Visit 1 when baseline assessment of their bowel movements over the previous 14 days were made Patients were dispensed with Movicol to commence treatment on the following day Day 1 During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved Thereafter until the end of the study the dosage was titrated according to the stool consistency diarrhoea loose stool hard stools or no bowel movement for 2 days respectively
Four on-treatment visits were performed on Day 14 Visit 2 Day 28 Visit 3 Day 56 Visit 4 and Day 84 Visit 5 At each visit bowel movements over the previous period were assessed by the investigator using the patients daily diary card data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None