Evaluation of effect of motilium as adjuvant therapy with polyethylene glycol in treatment of chronic functional constipation in children in comparison to placebo
This study is a double blind clinical trial that perform in two groups of 50 children aged less than 12 year with chronic functional constipation. These two groups will be sex and age matched. For treatment of constipation, family education, diet, regular toilet training and disimpaction will be the same in both groups. One group will be treating with polyethylene glycol 0.6 mg/kg/day twice daily for six months and motilium 0.15 mg/kg/day three times per day for three months. Another group will be treating with the same dose of polyethylene glycol for six months and placebo for three months. The bottles are tagged by pharmacist as code 01 and 02. The patients refer to pharmacist and he prescribes polyethylene glycol and 01 or 02 syrup every other one. All patients will be following at one, three and six months after trial. In each visit Rome III criteria are evaluated and persistence of less than two criteria will considering as response to treatment. Finally two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204259101N2
Registration date:2012-06-13, 1391/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-13, 1391/03/24
Registrant information
Name
Seyed Mohsen Dehghani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 1775
Email address
dehghanism@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of motilium as adjuvant therapy with polyethylene glycol in treatment of chronic functional constipation in children in comparison to placebo
Public title
Evaluation of effect of motilium in treatment of chronic functional constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having Rome III criteria for definition of functional constipation. Two or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of inflammatory bowel syndrome: Two or fewer defecations in the toilet per week; At least 1 episode of fecal incontinence per week; history of retentive posturing or excessive volitional stool retention; History of painful or hard bowel movements; Presence of a large fecal mass in the rectum; History of large diameter stools Criteria fulfilled at least once per week for at least 2 months before diagnosis, and one month of at least two of the following in infants up to 4 years of age: Two or fewer defecations per week; At least one episode/week of incontinence after the acquisition of toileting skills; History of excessive stool retention; History of painful or hard bowel movements ; Presence of a large fecal mass in the rectum; History of large diameter stools. The exclusion criteria: constipation due to any organic causes such as Hirschsprung disease, hypothyroidism, anal stenosis or use of medications that cause constipation.
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
89-01-01-2580
Health conditions studied
1
Description of health condition studied
chronic constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
constipation
Timepoint
before intervention, one month and three months after intervention, and three months after the end of intervention
Method of measurement
Rome III criteria
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with polyethylene glycol 0.6 gram/Kg/day two times a day for 6 months and motilium syrup 0.15 mg/Kg/dose three times a day for 3 months (1 mL=1 mg Syrup)
Category
Treatment - Drugs
2
Description
Treatment with polyethylene glycol 0.6 gram/Kg/day two times a day for 6 months and placebo syrup 0.15 mL/Kg/dose three times a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Nemazee Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohsen Dehghani
Position
Associate Professor
Other areas of specialty/work
Street address
Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4298
Fax
Email
dehghanism@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohsen Dehghani
Position
Associate Professor
Other areas of specialty/work
Street address
Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4298
Fax
Email
dehghanism@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohsen Dehghani
Position
Associate Professor
Other areas of specialty/work
Street address
Nemazee Hospital
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)