Chronic ConstipationPhase 3NCT00403897
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
A Phase 3 study testing Polyethylene glycol 3350 Na bicarbonate NaCl KCl in people with Chronic Constipation, run by Norgine at 1 site in Australia.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children. Read more about this study
- Who is it for?
- Ages 24 months to 11 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Polyethylene glycol 3350 Na bicarbonate NaCl KCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2001to Jan 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.
Read the 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 patient's daily diary card data.
- Conditions
- Chronic Constipation
- Being tested
- Polyethylene glycol 3350 Na bicarbonate NaCl KCl
- Keywords
- Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol 3350 Na bicarbonate NaCl KClDrug
Also called MOVICOL
6.9g sachet, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ages 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 \& 5 = 2 sachets BID; Receives: Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Secondary outcomes (11)
Assessment of
abdominal pain
amount of stool
faecal form (Bristol stool scale)
rectal bleeding
pain on defaecation
straining on defaecation
stool withholding
faecal incontinence (soiling)
efficacy (investigator and parental assessment)
concomitant laxative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startAug 2001
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Winita Hardikar, MD, Principal investigator, Royal Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403897
- Sponsor's protocol ID
- 99/04
- Status last verified
- Apr 2008
- First submitted
- 24 Nov 2006
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9895382
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children
- ClinicalTrials.gov ID
- NCT00403897
- Acronym / sponsor ID
- 99/04
- Conditions
- Chronic Constipation
- Keywords
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Jan 2003
- First posted
- 27 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's daily diary card data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KClAges 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 \& 5 = 2 sachets BID; |
Who may qualify
- Ages
- 24 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- children aged 24 months - 11 years old inclusive
- patients with constipation defined as:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycol 3350 Na bicarbonate NaCl KClAlso: MOVICOL6.9g sachet, oral | Drug | 1 |
Primary outcome
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
11 secondary outcomes
Assessment of
abdominal pain
amount of stool
faecal form (Bristol stool scale)
rectal bleeding
pain on defaecation
straining on defaecation
stool withholding
faecal incontinence (soiling)
efficacy (investigator and parental assessment)
concomitant laxative treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2008.
- Background: PubMed 9895382Attar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winita Hardikar, MD principal investigator
Royal Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyethylene glycol 3350 Na bicarbonate NaCl KCl in people with Chronic Constipation, run by Norgine at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2008.