ConstipationPhase 3NCT00796354
Constipation Associated With Irritable Bowel Syndrome (IBS-C)
A Phase 3 study testing MOVICOL and Sugar Pill in people with Constipation, run by Norgine at 21 sites in 7 countries.
Trial summary
Multi-centre, double-blind, randomised, placebo-controlled, parallel group study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Constipation
- What is being tested?
- MOVICOL and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Nov 2008to Feb 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females aged 18 to 80 years inclusive.
- Written informed consent obtained.
- Females of child-bearing potential must employ an adequate method of contraception and must undergo a pregnancy test at Randomisation Visit.
- Willing, able and competent to complete the entire study and comply with study instructions.
- Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
- Patient has diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis.
Who cannot join
- History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome.
- Abdominal pain of unknown cause, not related to IBS.
- Previous major abdominal surgery.
- IBS subtype other than IBS-C.
- Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.
- Laxative, drug or alcohol abuse (recent history or within previous 12 months).
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- Pregnant or lactating females.
- Severe or acute disease within 2 weeks prior to the start of the study.
- Patients with type I or II diabetes.
- Use of other investigational drugs, prescribed or OTC medications affecting gastrointestinal function such as anticholinergics, prokinetics, drugs affecting motility, anthraquinones, opioids,ondansetron or other 5-HT3 antagonists.
- Incomplete Patient Diary Card during the run-in period.
- The occurrence of diarrhoea* during the run-in period.
- Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation.
- Patients with any condition, which, in the Investigator's may put the patient at significant risk, may confound the study results, or may interfere significantly with the results of the study.
- Participation in another clinical study of drugs or devices parallel to or less than 1 month before study entry, or previous participation in this study.
- Employees of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
Italy4 sites
Policlinico S. Orsola Malpighi
Bologna, 40138
Università degli Studi di Genova
Genova, 6 - 16132
Università degli Studi di Palermo
Palermo, 129 - 90127
Università La Sapienza
Roma, 00162
Poland4 sites
Slaskie Centrum Osteoporozy
Katowice, 40-084
Prosen SMO
Warsaw, 01-231
Centrum Onkologii ul.Rentgena 5
Warsaw, 02-781
Katedra i Klinika Gastroenterologii i Hepatologii
Wroclaw, 50-556
Czechia3 sites
Gastroenterologie s.r.o.
Hradec Králové, 500 02
EGK.s.r.o, Sanatorium sv. Anny
Prague, 130 00
Orlickoustecká Nemocnice a.s.
Ústi Nad Orlicí, 562 18
France3 sites
Hôpital Hotel Dieu
Clermont-Ferrand, 63058
Hôpital Archet II
Nice, 06200
Hôpital Charles Nicolles
Rouen, 76031
Germany3 sites
Martin-Luther-Krankenhaus-Betriebs-GmbH
Berlin, 14193
Gastroenterologische Gemeinschaftspraxis
Münster, 48159
Facharztpraxis für Innere Medizin
Wiesbaden, 65185
Sweden2 sites
Sodra Alvsborgs Hospital (SAS)
Borås, SE-176-65
Karolinska University Hospital Solna
Stockholm, SE-171-76
United Kingdom2 sites
St Marks Hospital
Harrow, HA1 3UJ
John Radcliffe Hospital
Oxford, OX3 9DU
About this study
Official title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® With Placebo in Patients With Constipation Associated With Irritable Bowel Syndrome (IBS)
Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.
Read the detailed description
Patients will be treated for 28 days, with clinical assessments carried out over 2 visits. Follow-up will be performed via telephone at a specific interval during the study to determine the outcome of unresolved AEs, any new drug-related AEs or any pregnancies. During the run-in period and the treatment phase, patients are prohibited from taking prescription or over the counter (OTC) laxative medication or constipating medications. Prescription and OTC medications not related to constipation are permitted and must be fully documented, but any changes (e.g., dosage, regimen) are to be limited as much as possible.
- Conditions
- Constipation
- Being tested
- MOVICOL, Sugar Pill
- Keywords
- Constipation, Irritable Bowel Syndrome
- Medical subject headings
- Constipation, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVICOLDrug
Also called Macrogol (PEG) 3350, sodium chloride, sodium bicarbonate, potassium chloride
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
Sugar PillDrug
Also called Sucrose, lemon and lime flavour
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| NRL920 | Active comparator | Not described Receives: Drug: MOVICOL |
| Placebo | Placebo comparator | Not described Receives: Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS.
Measured: April 2009
Secondary outcomes (2)
To evaluate the effect of treatment on other symptoms of IBS.
Measured: April 2009
To evaluate the effect of treatment on patient's Quality Of Life (QOL).
Measured: April 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roger Chapman, MD, Principal investigator, Oxford University Hospitals NHS TrustMike Geraint, MD, Study director, Norgine Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796354
- Sponsor's protocol ID
- NRL920-01/2008 (IBSc)
- Status last verified
- Feb 2010
- First submitted
- 21 Nov 2008
- Last updated
- 17 Feb 2010
- 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 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® With Placebo in Patients With Constipation Associated With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT00796354
- Acronym / sponsor ID
- NRL920-01/2008 (IBSc)
- Conditions
- Constipation
- Keywords
- Constipation, Irritable Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Nov 2008 (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.
Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.
Detailed description
Patients will be treated for 28 days, with clinical assessments carried out over 2 visits. Follow-up will be performed via telephone at a specific interval during the study to determine the outcome of unresolved AEs, any new drug-related AEs or any pregnancies. During the run-in period and the treatment phase, patients are prohibited from taking prescription or over the counter (OTC) laxative medication or constipating medications. Prescription and OTC medications not related to constipation are permitted and must be fully documented, but any changes (e.g., dosage, regimen) are to be limited as much as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NRL920 | Active comparator | Drug: MOVICOL |
| Placebo | Placebo comparator | Drug: Sugar Pill |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and females aged 18 to 80 years inclusive.
- Written informed consent obtained.
- Females of child-bearing potential must employ an adequate method of contraception and must undergo a pregnancy test at Randomisation Visit.
- Willing, able and competent to complete the entire study and comply with study instructions.
- Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
Key exclusion criteria (16 listed)
- History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome.
- Abdominal pain of unknown cause, not related to IBS.
- Previous major abdominal surgery.
- IBS subtype other than IBS-C.
- Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.
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 |
|---|---|---|
| MOVICOLAlso: Macrogol (PEG) 3350, sodium chloride, sodium bicarbonate, potassium chloridesealed laminated sachet, 1 - 3 sachets daily for 4 weeks | Drug | NRL920 |
| Sugar PillAlso: Sucrose, lemon and lime flavoursealed laminated sachet, 1 - 3 sachets daily for 4 weeks | Drug | Placebo |
Primary outcome
To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS.
Time frame: April 2009
2 secondary outcomes
To evaluate the effect of treatment on other symptoms of IBS.
Time frame: April 2009
To evaluate the effect of treatment on patient's Quality Of Life (QOL).
Time frame: April 2009
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 17 Feb 2010.
- 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.
Roger Chapman, MD principal investigator
Oxford University Hospitals NHS Trust
Mike Geraint, MD study director
Norgine Pharmaceuticals Ltd
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MOVICOL and Sugar Pill in people with Constipation, run by Norgine at 21 sites in 7 countries.
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 6 inclusion and 16 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy, Poland, Czechia, France, Germany and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS. (time frame: April 2009). 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 NCT00796354, 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 17 Feb 2010.