Trial Outcomes & Findings for Canadian Active & Maintenance Modified Pentasa Study (NCT NCT00603733)
NCT ID: NCT00603733
Last Updated: 2016-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
288 participants
Primary outcome timeframe
From baseline to week 8
Results posted on
2016-04-22
Participant Flow
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.
Participant milestones
| Measure |
Pentasa® Modified Extended Release
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Active Phase ITT
STARTED
|
95
|
95
|
|
Active Phase ITT
COMPLETED
|
84
|
78
|
|
Active Phase ITT
NOT COMPLETED
|
11
|
17
|
|
Run-In Phase - 4 Weeks
STARTED
|
49
|
49
|
|
Run-In Phase - 4 Weeks
COMPLETED
|
35
|
36
|
|
Run-In Phase - 4 Weeks
NOT COMPLETED
|
14
|
13
|
|
Maintenance Phase ITT
STARTED
|
71
|
82
|
|
Maintenance Phase ITT
COMPLETED
|
61
|
66
|
|
Maintenance Phase ITT
NOT COMPLETED
|
10
|
16
|
Reasons for withdrawal
| Measure |
Pentasa® Modified Extended Release
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Active Phase ITT
Adverse Event
|
8
|
7
|
|
Active Phase ITT
Withdrawal by Subject
|
0
|
3
|
|
Active Phase ITT
Lost to Follow-up
|
0
|
1
|
|
Active Phase ITT
Did not meet inclusion/exclusion
|
1
|
3
|
|
Active Phase ITT
Lack of Efficacy
|
1
|
2
|
|
Active Phase ITT
Subject moved, site closed
|
1
|
1
|
|
Run-In Phase - 4 Weeks
Adverse Event
|
2
|
1
|
|
Run-In Phase - 4 Weeks
Withdrawal by Subject
|
4
|
1
|
|
Run-In Phase - 4 Weeks
Lost to Follow-up
|
1
|
0
|
|
Run-In Phase - 4 Weeks
Did not meet incl/excl criteria
|
5
|
10
|
|
Run-In Phase - 4 Weeks
Lack of Efficacy
|
2
|
1
|
|
Maintenance Phase ITT
Adverse Event
|
3
|
6
|
|
Maintenance Phase ITT
Withdrawal by Subject
|
1
|
0
|
|
Maintenance Phase ITT
Protocol Violation
|
1
|
1
|
|
Maintenance Phase ITT
Lost to Follow-up
|
0
|
1
|
|
Maintenance Phase ITT
Lack of Efficacy
|
2
|
2
|
|
Maintenance Phase ITT
Physician Decision
|
0
|
1
|
|
Maintenance Phase ITT
Site withdrew, subject away, lost IMP
|
3
|
5
|
Baseline Characteristics
Canadian Active & Maintenance Modified Pentasa Study
Baseline characteristics by cohort
| Measure |
Pentasa® Modified Extended Release
n=139 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
n=146 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Active Phase
|
44.2 years
STANDARD_DEVIATION 12.88 • n=39 Participants
|
44.5 years
STANDARD_DEVIATION 12.53 • n=41 Participants
|
44.35 years
STANDARD_DEVIATION 12.71 • n=35 Participants
|
|
Age, Continuous
Maintenance Phase
|
46.4 years
STANDARD_DEVIATION 12.20 • n=39 Participants
|
45.8 years
STANDARD_DEVIATION 13.45 • n=41 Participants
|
46.1 years
STANDARD_DEVIATION 12.83 • n=35 Participants
|
|
Age, Customized
Active Phase
|
45 years
n=39 Participants
|
43.5 years
n=41 Participants
|
44.3 years
n=35 Participants
|
|
Age, Customized
Maintenance Phase
|
48 years
n=39 Participants
|
44.5 years
n=41 Participants
|
46.3 years
n=35 Participants
|
|
Sex/Gender, Customized
Active Phase, Female
|
30 participants
n=39 Participants
|
34 participants
n=41 Participants
|
64 participants
n=35 Participants
|
|
Sex/Gender, Customized
Active Phase, Male
|
48 participants
n=39 Participants
|
44 participants
n=41 Participants
|
92 participants
n=35 Participants
|
|
Sex/Gender, Customized
Maintenance Phase, Female
|
28 participants
n=39 Participants
|
29 participants
n=41 Participants
|
57 participants
n=35 Participants
|
|
Sex/Gender, Customized
Maintenance Phase, Male
|
33 participants
n=39 Participants
|
39 participants
n=41 Participants
|
72 participants
n=35 Participants
|
|
Region of Enrollment
Canada
|
139 participants
n=39 Participants
|
146 participants
n=41 Participants
|
285 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 8Population: Per Protocol Analysis Set
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.
Outcome measures
| Measure |
Pentasa® Modified Extended Release
n=78 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
n=78 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Active Phase: Proportion of Active Subjects Achieving Overall Improvement
|
64.1 percentage of participants
Interval 55.17 to 73.04
|
69.2 percentage of participants
Interval 60.63 to 77.83
|
PRIMARY outcome
Timeframe: Up to week 24Population: Per Protocol Analysis Set
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy
Outcome measures
| Measure |
Pentasa® Modified Extended Release
n=61 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
n=68 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Maintenance Phase: Proportion of Subjects Experiencing Relapse
|
24.6 % of subjects with relapse (90% CI)
Interval 15.52 to 33.66
|
11.8 % of subjects with relapse (90% CI)
Interval 5.34 to 18.19
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: Safety dataset for Active and Maintenance Phases
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.
Outcome measures
| Measure |
Pentasa® Modified Extended Release
n=143 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
n=144 Participants
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Frequency of Adverse Events
|
52.4 percentage of patients with TEAEs
|
45.1 percentage of patients with TEAEs
|
Adverse Events
Pentasa® Modified Extended Release
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Pentasa®
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pentasa® Modified Extended Release
n=143 participants at risk
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
n=144 participants at risk
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Infections and infestations
Sepsis
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Investigations
Haemoglobin decreased
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.70%
1/143 • Number of events 1 • 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.
|
0.00%
0/144 • 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.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/143 • 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.
|
0.69%
1/144 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/143 • 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.
|
0.69%
1/144 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Pentasa® Modified Extended Release
n=143 participants at risk
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)
|
Pentasa®
n=144 participants at risk
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet
|
|---|---|---|
|
Gastrointestinal disorders
Colitis Ulcerative
|
2.8%
4/143 • Number of events 4 • 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.
|
6.2%
9/144 • Number of events 10 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
8.4%
12/143 • Number of events 15 • 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.
|
4.2%
6/144 • Number of events 8 • 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.
|
|
Nervous system disorders
Headache
|
7.7%
11/143 • Number of events 12 • 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.
|
9.0%
13/144 • Number of events 15 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER