Chronic ConstipationPhase 3NCT00403819
Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
A Phase 3 study testing Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol) in people with Chronic Constipation, run by Norgine at 6 sites in United Kingdom.
Trial summary
A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety 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 (Movicol)
- How many people
- 60 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Apr 2002to Apr 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
- Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.
- informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study
- aged 24 months - 11 years
- experiencing constipation as defined as:
- ≤2 complete bowel movements per week, and at least one of the following:
- pain on defaecation on ≥1 in 4 days
Show all 10Show fewer
- 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
- available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents.
Who cannot join
- Patients will not be eligible to participate in the study if any of the following conditions apply:
- faecal impaction or history of faecal impaction
- history of intestinal perforation or constipation
- paralytic ileus
- toxic megacolon
- Hirschsprungs disease
Show all 15Show fewer
- severe inflammatory conditions of the intestinal tract
- severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis, respiratory aspiration, failure to thrive or other recognised complications of gastro-oesophageal reflux
- patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per day for children > 6 years (i.e. high doses of stimulant laxatives)
- any other significant medical condition that in the investigator's opinion would effect their suitability for entry into the study
- patients who have previously received Movicol or previously participated in the study
- known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of Movicol
- patients with diabetes as the placebo to be used in this study is sucrose
- patients who have received any investigational drug in the last 3 months
- patients and/or parents who the investigator thinks could not comply with the requirements of the protocol for any reason (particularly in relation to reliable completion of diary cards)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Aberdeen Children's Hospital
Aberdeen, AB25 2ZN
University Hospital of Wales, Children's Hospital, North Ward
Cardiff, CF14 4XW
Royal Hospital for Sick Children, University Hospitals NHS Trust
Edinburgh, EH9 1LF
Leicester Royal Infirmary
Leicester, LE1 5WW
Royal Free Hospital
London, NW3 2PF
New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: A Phase III Multi-Centre Placebo-Controlled Crossover Study Followed by an Open Label Post-Study Follow-up to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children
Read the detailed description
After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks.
On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.
- Conditions
- Chronic Constipation
- Being tested
- Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)
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 KCl (Movicol)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of complete defaecations per week in each treatment period
Secondary outcomes (6)
Mean total number of defaecations (complete plus incomplete) per week in each treatment period
Pain on defaecation
Straining on defaecation
Abdominal pain
Faecal incontinence
Stool consistency
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 startApr 2002
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael A Thomson, MD, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403819
- Sponsor's protocol ID
- 2000/01
- Status last verified
- Nov 2006
- First submitted
- 24 Nov 2006
- Last updated
- 28 Nov 2006
- Results posted
- No
Publications
Issenman RM, Hewson S, Pirhonen D, Taylor W, Tirosh A. Are chronic digestive complaints the result of abnormal dietary patterns? Diet and digestive complaints in children at 22 and 40 months of age. Am J Dis Child. 1987 Jun;141(6):679-82. doi: 10.1001/archpedi.1987.04460060095043.
PubMed 3578195Hatch TF. Encopresis and constipation in children. Pediatr Clin North Am. 1988 Apr;35(2):257-80. doi: 10.1016/s0031-3955(16)36431-8.
PubMed 3278282Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. doi: 10.1136/gut.34.10.1400.
PubMed 8244110Benninga MA, Buller HA, Heymans HS, Tytgat GN, Taminiau JA. Is encopresis always the result of constipation? Arch Dis Child. 1994 Sep;71(3):186-93. doi: 10.1136/adc.71.3.186.
PubMed 7979489Benninga MA, Buller HA, Tytgat GN, Akkermans LM, Bossuyt PM, Taminiau JA. Colonic transit time in constipated children: does pediatric slow-transit constipation exist? J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):241-51. doi: 10.1097/00005176-199610000-00007.
PubMed 8890073Culbert P, Gillett H, Ferguson A. Highly effective new oral therapy for faecal impaction. Br J Gen Pract. 1998 Sep;48(434):1599-600.
PubMed 9830188Thomson M, Jenkins H, et al. A Placebo Controlled Crossover Study of Movicol in the Treatment of Childhood Constipation. J Pediatr Gastroenterol Nutr 2004;39(1):S16 [abstract]
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multi-Centre Placebo-Controlled Crossover Study Followed by an Open Label Post-Study Follow-up to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
- ClinicalTrials.gov ID
- NCT00403819
- Acronym / sponsor ID
- 2000/01
- Conditions
- Chronic Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Apr 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.
A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children
Detailed description
After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks.
On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 24 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.
- informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study
- aged 24 months - 11 years
- experiencing constipation as defined as:
- patients in whom these symptoms have been present for ≥3 months
Key exclusion criteria (15 listed)
- Patients will not be eligible to participate in the study if any of the following conditions apply:
- faecal impaction or history of faecal impaction
- history of intestinal perforation or constipation
- paralytic ileus
- toxic megacolon
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 KCl (Movicol) | Drug | – |
Primary outcome
Mean number of complete defaecations per week in each treatment period
6 secondary outcomes
Mean total number of defaecations (complete plus incomplete) per week in each treatment period
Pain on defaecation
Straining on defaecation
Abdominal pain
Faecal incontinence
Stool consistency
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 28 Nov 2006.
- Background: PubMed 3578195Issenman RM, Hewson S, Pirhonen D, Taylor W, Tirosh A. Are chronic digestive complaints the result of abnormal dietary patterns? Diet and digestive complaints in children at 22 and 40 months of age. Am J Dis Child. 1987 Jun;141(6):679-82. doi: 10.1001/archpedi.1987.04460060095043.
- Background: PubMed 3278282Hatch TF. Encopresis and constipation in children. Pediatr Clin North Am. 1988 Apr;35(2):257-80. doi: 10.1016/s0031-3955(16)36431-8.
- Background: PubMed 8244110Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. doi: 10.1136/gut.34.10.1400.
- Background: PubMed 7979489Benninga MA, Buller HA, Heymans HS, Tytgat GN, Taminiau JA. Is encopresis always the result of constipation? Arch Dis Child. 1994 Sep;71(3):186-93. doi: 10.1136/adc.71.3.186.
- Background: PubMed 8890073Benninga MA, Buller HA, Tytgat GN, Akkermans LM, Bossuyt PM, Taminiau JA. Colonic transit time in constipated children: does pediatric slow-transit constipation exist? J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):241-51. doi: 10.1097/00005176-199610000-00007.
- Background: PubMed 9830188Culbert P, Gillett H, Ferguson A. Highly effective new oral therapy for faecal impaction. Br J Gen Pract. 1998 Sep;48(434):1599-600.
- Results publicationThomson M, Jenkins H, et al. A Placebo Controlled Crossover Study of Movicol in the Treatment of Childhood Constipation. J Pediatr Gastroenterol Nutr 2004;39(1):S16 [abstract]
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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.
Michael A Thomson, MD principal investigator
Royal Free Hospital NHS Foundation Trust
6 sites 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 (Movicol) in people with Chronic Constipation, run by Norgine at 6 sites in United Kingdom.
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 28 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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?
Mean number of complete defaecations per week in each treatment period. 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 NCT00403819, which also lists 7 linked publications.
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 28 Nov 2006.