Condition category
Signs and Symptoms
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.A. Benninga

ORCID ID

Contact details

Academic Medical Center
Pediatric Department
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663053
m.a.benninga@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR399

Study information

Scientific title

Acronym

Study hypothesis

1. We hypothesise that children with solitary encopresis have a disturbed compensation reflex, eventually combined with aberrant huge rectal contractions
2. We hypothesise that in children with solitary encopresis loperamide rectally given, will reduce rectal activity and consequently exert its clinical effect

Ethics approval

Received from local medical ethics committee

Study design

Randomised double blind placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Encopresis, solitary

Intervention

Period 1: 1 month suppositories either placebo or loperamide twice daily 5 mg + diary chart.
Combine rectal manometry and barostat at end of period.
Period 2: 1 month wash-out + diary chart.
Period 3: 1 month suppositories either placebo or loperamide twice daily 5 mg + diary chart.
Combine rectal manometry and barostat at end of period.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Encopresis frequency
2. Rectal function: comparison between loperamide and placebo period

Secondary outcome measures

3. Side effects of loperamide suppositories

Overall trial start date

01/01/2003

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

To enter the study the patients have to fulfil the following criteria:
1. Encopresis frequency of ≥ 2 times/week
2. Colonic transit time ≥ 62 hours
3. At least 3 years treatment without success (biofeedback training, laxatives, toilet training)
4. Age of the child ≥ 8 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Colonic transit time >62 hours
2. Other signs of constipation:
2.1. Defecation frequency <2 times per week
2.2. Periodic passage of very large amounts of stool
2.3. A palpable abdominal or rectal mass
3. Anorectal malformations
4. Impaired neurological functioning such as spina bifida
5. Evident psychiatric diagnosis such as depressive disorder
6. Metabolic diseases
7. Using drugs influencing gastrointestinal motility
8. Mental retardation
9. Any abdominal or anorectal surgical intervention
10. Hirschsprung’s disease
11. Any other (gastrointestinal) disease with a possible influence on gastrointestinal motility

Recruitment start date

01/01/2003

Recruitment end date

01/08/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (Netherlands)

Sponsor details

Pediatric Department
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands) - Department of Pediatrics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes