Movicol in Childhood Constipation (ProMotion Study) | NCT00403858

Studies
Movicol in Childhood Constipation (ProMotion Study)

NCT00403858

Sponsor

Norgine

Status

Completed

Last Update Posted

Jan 4, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Feces, Impacted

Interventions

Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
Lactulose

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Apr 2002

First Submitted Date

Nov 24, 2006

First Submission Date that Met QC Criteria

Nov 24, 2006

First Posted Date

Nov 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2007

Last Update Posted Date

Jan 4, 2007Estimated

Description Module

Brief Summary

This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.

Detailed Description

Patients received Movicol treatment until disimpaction was achieved according to the following regime:

Day 1: Ages 2 - 4 received 1 (one) sachet whilst 5 - 11 year olds received 2 (two).

Day 2: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 3 (three).

Day 3: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 4 (four).

Day 4: Ages 2 - 4 received 3 *three) sachets whilst 5 - 11 year olds received 5 (five).

Day 5: Ages 2 - 4 received 3 (three) sachets whilst 5 - 11 year olds received 6 (six).

Day 6: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six).

Day 7: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six).

If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs. Disimpaction was assessed clinically (loss of faecal masses and passage of watery stools).

Two days following disimpaction patients were randomised (according to the randomisation list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once they were passing regular, painless, bowel actions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction
children aged 2 - 11 years old inclusive
patients of either sex

Exclusion Criteria:

Patients with

intestinal perforation or obstruction
severe inflammatory conditions of the intestinal tract
uncontrolled renal/hepatic/cardiac diseases
uncontrolled endocrine disorder(s)
any neuromuscular condition affecting bowel function
hypersensitivity to lactulose or PEG or other constituent of Movicol
patients who have taken any investigational drug in the three months
patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David CA Candy, MD	St. Richard's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Richard's Hospital, Royal West Sussex Hospital NHS Trust		Chichester		PO19 4SE	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Dalziel SR et al. Efficacy of Movicol in children with faecal impaction. A series of en case histories (A13). British Society of Paediatric Gastroenterologists Annual Meeting. Bristol:21-22, Jan 2000
9895382	Background	Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.
16819379

ID	Term
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Name	Type	Description	Arm Group Labels	Other Names
Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)	Drug
Lactulose	Drug