Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentasa® modified extended release | Experimental | 5-ASA (5-Aminosalicylate) |
|
| Pentasa® | Active Comparator | 5-ASA (5-Aminosalicylate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ASA (5-Aminosalicylate) | Drug | 500 mg tablet (modified extended release) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to week 24 |
Not provided
Inclusion Criteria for Active phase:
Inclusion Criteria for Maintenance phase:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary, Faculty of Medicine | Calgary | Alberta | Canada | |||
| Castledowns Medicentre |
Not provided
Total number of unique patients enrolled in the study is 288 whereby 190 patients were enrolled in the Active Phase and 98 patients were enrolled in the Run-In Phase.
The patients enrolled in the Maintenance Phase are a combination of patients who completed the Active (82) and Run In (71) Phases and were eligible to move forward into Maintenance.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pentasa® Modified Extended Release | 5-ASA (5-Aminosalicylate) 5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release) |
| FG001 | Pentasa® | 5-ASA (5-Aminosalicylate) 5-ASA (5-Aminosalicylate): 500 mg tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Active Phase ITT |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| 5-ASA (5-Aminosalicylate) | Drug | 500 mg tablet |
|
|
| Edmonton |
| Alberta |
| Canada |
| Investigational site | Brandon | Manitoba | Canada |
| Hilyard Place Building A | Saint John | New Brunswick | Canada |
| Barrie GI Associates | Barrie | Ontario | Canada |
| Investigational site | Greater Sudbury | Ontario | Canada |
| Investigational site | Guelph | Ontario | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | Canada |
| Investigational site | Oshawa | Ontario | Canada |
| Investigational site - Phenix Building | Ottawa | Ontario | Canada |
| Ottawa General Hospital | Ottawa | Ontario | Canada |
| Digestive Health Clinic | Richmond Hill | Ontario | Canada |
| Investigational site | Sarnia | Ontario | Canada |
| Investigational site | Thunder Bay | Ontario | Canada |
| JJ Dig Research Ltd | Toronto | Ontario | Canada |
| Keele Medical Place | Toronto | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Toronto Digestive Disease Association (TDDA) | Toronto | Ontario | Canada |
| Hotel Dieu Grace Hospital | Windsor | Ontario | Canada |
| Investigational site | Windsor | Ontario | Canada |
| Investigational site | Woodstock | Ontario | Canada |
| Hotel Dieu de Levis | Lévis | Quebec | Canada |
| Alpha Recherche Clinique Inc. | Loretteville | Quebec | Canada |
| Hopital Maissonneuve Rosemont | Montreal | Quebec | Canada |
| MUHC-Royal Victoria Hospital | Montreal | Quebec | Canada |
| Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital | Québec | Quebec | Canada |
| L'Hotel Dieu de Quebec | Québec | Quebec | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Run-In Phase - 4 Weeks |
|
|
| Maintenance Phase ITT |
|
|
Baseline characteristics were reported for the Per Protocol population who participated in the Active phase and in the maintenance phase of this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pentasa® Modified Extended Release | 5-ASA (5-Aminosalicylate) 5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release) |
| BG001 | Pentasa® | 5-ASA (5-Aminosalicylate) 5-ASA (5-Aminosalicylate): 500 mg tablet |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||
| Age, Customized | Median | Full Range | years |
| ||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol Analysis Set | Posted | Number | 90% Confidence Interval | percentage of participants | From baseline to week 8 |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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 | Per Protocol Analysis Set | Posted | Number | 90% Confidence Interval | % of subjects with relapse (90% CI) | Up to week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Safety dataset for Active and Maintenance Phases | Posted | Number | percentage of patients with TEAEs | From baseline to week 24 |
|
|
Adverse Event data is collected from the time Informed Consent is taken up to 28 days post study.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pentasa® Modified Extended Release | 5-ASA (5-Aminosalicylate) 5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release) | 7 | 143 | 27 | 143 | ||
| EG001 | Pentasa® | 5-ASA (5-Aminosalicylate) 5-ASA (5-Aminosalicylate): 500 mg tablet | 2 | 144 | 28 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Study was amended to modify sample size as subject enrolment was lower than anticipated. A data lock was imposed, pending completion of the Maintenance Phase by 12 subjects to report all Active Phase efficacy data & all available safety data.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
Not provided
Not provided
| Lost to Follow-up |
|
| Did not meet incl/excl criteria |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Site withdrew, subject away, lost IMP |
|
|
| Maintenance Phase |
|
| Active Phase, Male |
|
| Maintenance Phase, Female |
|
| Maintenance Phase, Male |
|
|
|