Active Ulcerative ColitisPhase 3CAMMPNCT00603733
Canadian Active & Maintenance Modified Pentasa Study
A Phase 3 study testing 5-ASA (5-Aminosalicylate) in people with Active Ulcerative Colitis and Remission of Ulcerative Colitis, run by Ferring Pharmaceuticals at 27 sites in Canada.
Trial summary
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Active Ulcerative Colitis, Remission of Ulcerative Colitis
- What is being tested?
- 5-ASA (5-Aminosalicylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 27 sitesCanada
- Study dates
- Oct 2007to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
- Extent of colonic involvement confirmed within the past 36 months
- UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
- Screening tests to rule out any abnormalities in stool, heart or kidney.
- Male or non-pregnant females between 18 to 75 years.
- Women of childbearing potential to use efficacious contraception as judged by the investigator.
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- Written informed consent given.
- Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease
- Subjects from Active Phase: meeting remission criteria after the 8-week active period
- Extent of colonic involvement confirmed within the past 36 months by colonoscopy
- In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1
- Screening tests to rule out any abnormalities in stool, heart or kidney.
Who cannot join
- Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.
- Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
- Infectious diseases, parasites, bacterial pathogens
- Allergy to aspirin or salicylate
- Liver or kidney abnormalities
- Alcohol or drug abuse
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- Pregnancy
- Cancer
- Bleeding disorders, ulcers, autoimmune diseases
- Mental disorders
- Participation in clinical trial in last 30 days
- Inability to fill in diary cards / comply with protocol requirements
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Canada27 sites
Barrie GI Associates
Barrie, Ontario
Investigational site
Brandon, Manitoba
University of Calgary, Faculty of Medicine
Calgary, Alberta
Castledowns Medicentre
Edmonton, Alberta
Investigational site
Greater Sudbury, Ontario
Investigational site
Guelph, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
Hotel Dieu de Levis
Lévis, Quebec
Alpha Recherche Clinique Inc.
Loretteville, Quebec
Hopital Maissonneuve Rosemont
Montreal, Quebec
MUHC-Royal Victoria Hospital
Montreal, Quebec
Investigational site
Oshawa, Ontario
Investigational site - Phenix Building
Ottawa, Ontario
Ottawa General Hospital
Ottawa, Ontario
Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
Québec, Quebec
L'Hotel Dieu de Quebec
Québec, Quebec
Digestive Health Clinic
Richmond Hill, Ontario
Hilyard Place Building A
Saint John, New Brunswick
Investigational site
Sarnia, Ontario
Investigational site
Thunder Bay, Ontario
JJ Dig Research Ltd
Toronto, Ontario
Keele Medical Place
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Toronto Digestive Disease Association (TDDA)
Toronto, Ontario
Hotel Dieu Grace Hospital
Windsor, Ontario
Investigational site
Windsor, Ontario
Investigational site
Woodstock, Ontario
About this study
Official title: A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.
Read the detailed description
A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.
Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.
- Being tested
- 5-ASA (5-Aminosalicylate)
- Keywords
- Ulcerative Colitis, 5-Aminosalicylate
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ASA (5-Aminosalicylate)Drug
Also called Pentasa®, mesalamine
500 mg tablet (modified extended release)
5-ASA (5-Aminosalicylate)Drug
Also called Pentasa®, mesalamine
500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Pentasa® modified extended release | Experimental | 5-ASA (5-Aminosalicylate) Receives: Drug: 5-ASA (5-Aminosalicylate) |
| Pentasa® | Active comparator | 5-ASA (5-Aminosalicylate) Receives: Drug: 5-ASA (5-Aminosalicylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Phase: Proportion of Active Subjects Achieving Overall Improvement
Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).
Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.
A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score.
Measured: From baseline to week 8
Maintenance Phase: Proportion of Subjects Experiencing Relapse
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy
Measured: Up to week 24
Secondary outcomes (1)
Frequency of Adverse Events
Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.
Measured: From baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Active Ulcerative ColitisStudies 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
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603733
- Sponsor's protocol ID
- CLN 35.3.11
- Acronym
- CAMMP
- Status last verified
- Apr 2016
- First submitted
- 16 Jan 2008
- Last updated
- 22 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks
- ClinicalTrials.gov ID
- NCT00603733
- Acronym / sponsor ID
- CAMMP / CLN 35.3.11
- Keywords
- Ulcerative Colitis, 5-Aminosalicylate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 22 Apr 2016
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 is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.
Detailed description
A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.
Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentasa® modified extended release | Experimental | Drug: 5-ASA (5-Aminosalicylate)5-ASA (5-Aminosalicylate) |
| Pentasa® | Active comparator | Drug: 5-ASA (5-Aminosalicylate)5-ASA (5-Aminosalicylate) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
- Extent of colonic involvement confirmed within the past 36 months
- UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
- Screening tests to rule out any abnormalities in stool, heart or kidney.
- Male or non-pregnant females between 18 to 75 years.
Key exclusion criteria (12 listed)
- Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.
- Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
- Infectious diseases, parasites, bacterial pathogens
- Allergy to aspirin or salicylate
- Liver or kidney abnormalities
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 |
|---|---|---|
| 5-ASA (5-Aminosalicylate)Also: Pentasa®, mesalamine500 mg tablet (modified extended release) | Drug | Pentasa® modified extended release |
| 5-ASA (5-Aminosalicylate)Also: Pentasa®, mesalamine500 mg tablet | Drug | Pentasa® |
Primary outcome
Active Phase: Proportion of Active Subjects Achieving Overall Improvement
Time frame: From baseline to week 8
Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI). Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1. A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score.
Maintenance Phase: Proportion of Subjects Experiencing Relapse
Time frame: Up to week 24
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy
1 secondary outcome
Frequency of Adverse Events
Time frame: From baseline to week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
27 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 5-ASA (5-Aminosalicylate) in people with Active Ulcerative Colitis and Remission of Ulcerative Colitis, run by Ferring Pharmaceuticals at 27 sites in Canada.
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 12 inclusion and 12 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 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Active Phase: Proportion of Active Subjects Achieving Overall Improvement (time frame: From baseline to week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2016.