Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00403897
Other study ID # 99/04
Secondary ID
Status Completed
Phase Phase 3
First received November 24, 2006
Last updated April 15, 2008
Start date August 2001
Est. completion date January 2003

Study information

Verified date April 2008
Source Norgine
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.


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 patient's daily diary card data.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date January 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 24 Months to 11 Years
Eligibility Inclusion Criteria:

- children aged 24 months - 11 years old inclusive

- patients with constipation defined as:

- = 2 spontaneous complete bowel movements per week (over the previous 14 days), and one or more of the following:

- 1/4 or more of bowel movements with straining

- 1/4 or more of bowel movements with hard or lumpy stools

- patients in whom these symptoms have been present for = 3 months

- new patients or those whose management is unsatisfactory on current laxative treatment

- patients of either sex

- patients of any ethnic origin

- hospital in-patients or outpatients.

Exclusion Criteria:

Patients with:

- history of bowel washout within the last 2 months

- intestinal perforation or history of obstruction

- recent history of urinary tract infection (within last month)

- Hirschsprungs disease

- paralytic ileus

- toxic megacolon

- severe inflammatory conditions of the intestinal tract

- clinically uncontrolled renal/hepatic/cardiac disease(s)

- clinically uncontrolled endocrine disorder(s)

- any other severe unstable co-existing disease

- hypersensitivity to macrogol or other constituents of Movicol

- encopresis

- patients who have taken any investigational drug in the last three months

- patients or patients whose parents would in the opinion of the investigator be unable to comply with the requirements of the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Polyethylene glycol 3350 Na bicarbonate NaCl KCl
6.9g sachet, oral

Locations

Country Name City State
Australia Royal Children's Hospital Parkville Victoria

Sponsors (1)

Lead Sponsor Collaborator
Norgine

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Secondary Assessment of
Secondary abdominal pain
Secondary amount of stool
Secondary faecal form (Bristol stool scale)
Secondary rectal bleeding
Secondary pain on defaecation
Secondary straining on defaecation
Secondary stool withholding
Secondary faecal incontinence (soiling)
Secondary efficacy (investigator and parental assessment)
Secondary concomitant laxative treatment
See also
  Status Clinical Trial Phase
Completed NCT05980988 - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation N/A
Recruiting NCT03819062 - Sacral Neuromodulation as Treatment for Chronic Constipation N/A
Completed NCT00730171 - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT00765882 - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation Phase 3
Completed NCT00354575 - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units Phase 2
Active, not recruiting NCT03119584 - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Phase 4
Completed NCT00765999 - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT01793753 - Effect of Propofol on Internal Anal Sphincter Pressure During ARM N/A
Completed NCT00746200 - Acupuncture for Chronic Constipation Phase 3
Enrolling by invitation NCT00671684 - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease Phase 1/Phase 2
Completed NCT00391820 - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial) Phase 2
Completed NCT00404040 - Movicol in Childhood Constipation (ProMotion Study) Phase 2
Completed NCT02281630 - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC) Phase 2
Completed NCT00256984 - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) Phase 4
Recruiting NCT05192317 - Administration of a Natural Molecular Complex in Functional Chronic Constipation N/A
Active, not recruiting NCT05202028 - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy N/A
Completed NCT05734859 - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation N/A
Completed NCT01007123 - Study of A3309 in Patients With Chronic Idiopathic Constipation Phase 2
Completed NCT00402337 - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation Phase 2
Completed NCT02961556 - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation Phase 3