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TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) (Precision-UC)

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ClinicalTrials.gov Identifier: NCT01903252
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Tillotts Pharma AG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Ulcerative Colitis
Interventions Drug: TP05
Drug: Asacol 400 mg
Enrollment 817
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TP05 (Mesalazine) 1600 mg Asacol (Mesalazine 400 mg) Extended Induction 1.6g TP05 (1600 mg) /Day Maintenance Open-Label 3.2g TP05 (1600 mg) /Day Maintenance Open-Label 4.8g TP05 (1600 mg) /Day Maintenance Open-Label
Hide Arm/Group Description 3.2g/day once daily (OD) for 12 weeks (blinded), 3.2g/d twice daily for 12 weeks (blinded), Non-responders at week 8 of the induction phase were taken out of the double-blind phase and treated with TP05 4.8g/day OD for another 8 weeks Remitters at week 12 of the induction phase received a daily dose of 1.6g OD in the maintenance phase open-label. Responders at week 12 of the induction phase remained on a daily dose of 3.2 g OD in the maintenance phase open-label. Non-responders at week 12 of the double-blind induction phase as well as non-responders at week 8 of the induction phase who responded after a second 8 weeks of extended induction treatments, were enrolled into the maintenance phase and remained on a daily dose of 4.8g OD.
Period Title: Double-Blind Induction
Started 409 408 0 0 0 0
Completed 370 367 0 0 0 0
Not Completed 39 41 0 0 0 0
Reason Not Completed
Adverse Event             20             18             0             0             0             0
Withdrawal by Subject             10             13             0             0             0             0
Physician Decision             2             3             0             0             0             0
non-compliance,             7             7             0             0             0             0
Period Title: Extended Induction, Open-Label
Started [1] 0 0 [1] 243 [2] 0 0 0
Completed 0 0 220 0 0 0
Not Completed 0 0 23 0 0 0
Reason Not Completed
Adverse Event             0             0             17             0             0             0
Withdrawal by Subject             0             0             5             0             0             0
Physician Decision             0             0             1             0             0             0
[1]
This treatment arm was only used in Period 1, double-blind induction phase.
[2]
The subjects in this phase were non-responders at week 8 and discontinued the double-blind phase.
Period Title: Maintenance, Open-Label
Started [1] 0 0 0 [2] 202 [3] 274 [3] 199 [3]
Completed 0 0 0 196 253 181
Not Completed 0 0 0 6 21 18
Reason Not Completed
Adverse Event             0             0             0             3             9             14
Withdrawal by Subject             0             0             0             1             6             2
Other             0             0             0             2             6             2
[1]

All patients received TP05, three diffrent daily doses:

1.6g, 3.2g, 4.8g

[2]
Period 2 (extended induction) is completed, subjects are newly allocated to Period 3, maintenance.
[3]
This is period 3, Open-Label Maintenance following on from period 1, the double-blind induction.
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG) Total
Hide Arm/Group Description 3.2 gram/day (g/d) once daily (OD) for 12 weeks (blinded), 3.2g/d twice daily for 12 weeks (blinded), Total of all reporting groups
Overall Number of Baseline Participants 409 408 817
Hide Baseline Analysis Population Description
Safety Population (SAF)/Intent to Treat (ITT)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 409 participants 408 participants 817 participants
43.97  (14.54) 43.3  (14.11) 43.5  (14.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 409 participants 408 participants 817 participants
Female
171
  41.8%
178
  43.6%
349
  42.7%
Male
238
  58.2%
230
  56.4%
468
  57.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 409 participants 408 participants 817 participants
White
378
  92.4%
386
  94.6%
764
  93.5%
Black
1
   0.2%
1
   0.2%
2
   0.2%
Asian or Pacific Islander
7
   1.7%
3
   0.7%
10
   1.2%
Mixed/Other
0
   0.0%
1
   0.2%
1
   0.1%
Not Available
23
   5.6%
17
   4.2%
40
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 409 participants 408 participants 817 participants
Belarus 47 49 96
Belgium 9 8 17
Bulgaria 15 15 30
Canada 15 17 32
Czech Republic 20 18 38
Denmark 20 16 36
Finland 2 1 3
Hungary 17 11 28
France 23 16 39
Ireland 1 0 1
Latvia 22 22 44
Lithuania 26 28 54
Norway 4 5 9
Poland 44 48 92
Romania 2 1 3
Russian Federation 51 50 101
Serbia 18 18 36
Slovakia 2 3 5
Spain 0 2 2
Sweden 1 2 3
Ukraine 59 71 130
United Kingdom 11 7 18
Mayo Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 409 participants 408 participants 817 participants
7.7  (1.3) 7.6  (1.3) 7.7  (1.3)
[1]
Measure Description:

Mayo Score and Partial Mayo Clinic Score (PMCS):

The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician’s global assessment. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease in all sub-scores).

Partial Mayo Clinic Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 409 participants 408 participants 817 participants
5.5  (1.1) 5.3  (1.1) 5.4  (1.1)
[1]
Measure Description: Partial Mayo Clinic Score (PMCS) is the sum of the component sub-scores, excluding the endoscopic score. The 3 component sub-scores are: 1) stool frequency, 2) rectal bleeding, and 3) physician's global assessment. The minimum is 0, no pathology and the maximum is 9, severe disease in all sub-scores.
1.Primary Outcome
Title Period 1: Clinical and Endoscopic Remission
Hide Description Mayo Score of <= 2 points with no individual sub-score > 1
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded),
3.2g/d twice daily for 12 weeks (blinded),
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
87
  22.4%
95
  24.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-8.1 to 3.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Period 2: Clinical Response, Open-Label Extended Induction
Hide Description A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Extended Induction
Hide Arm/Group Description:
Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
183
  75.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended Induction
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentag
Estimated Value 75.3
Confidence Interval (2-Sided) 95%
69.4 to 80.6
Estimation Comments [Not Specified]
3.Primary Outcome
Title Period 3: Clinical Remission
Hide Description Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participant
70.3 33.9 30.7
4.Secondary Outcome
Title Period 1: Endoscopic Remission
Hide Description Endoscopic remission was defined as a Mayo endoscopy subscore of 0
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded),
3.2g/d twice daily for 12 weeks (blinded),
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
36
   9.3%
44
  11.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-6.5 to 2.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Period 1: Endoscopic Response
Hide Description Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
185
  47.7%
196
  50.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-10.1 to 3.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Period 1: Clinical Remission
Hide Description Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
92
  23.7%
110
  28.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-10.9 to 1.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Period 1: Rectal Bleeding Sub-score of 0
Hide Description Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
212
  54.6%
226
  58.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-Inferiority
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Non-inferiortiy
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-10.8 to 3.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Period 1: Clinical and Endoscopic Response
Hide Description Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
Hide Arm/Group Description:
3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
221
  57.0%
236
  61.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-Inferiority
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-11.0 to 2.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Period 1: Clinical Remission
Hide Description Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
93
  24.0%
113
  29.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-11.5 to 0.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Period 1: Clinical Response
Hide Description A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
223
  57.5%
233
  60.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Non-inferiortiy
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-9.8 to 4.0
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Period 1: Rectal Bleeding Score of 0
Hide Description Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
193
  49.7%
205
  53.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Non-inferiortiy
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-10.3 to 3.7
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Period 1: Clinical Remission at Both Week 8 and 12
Hide Description Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame Week 8 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
66
  17.0%
80
  20.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-9.2 to 1.8
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Period 1: Clinical Response at Both Week 8 and Week 12
Hide Description A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine, Tillotts Pharma AG)
Hide Arm/Group Description:
3.2g/day once daily for 12 weeks (blinded)
3.2g/d twice daily for 12 weeks (blinded)
Overall Number of Participants Analyzed 388 386
Measure Type: Count of Participants
Unit of Measure: Participants
216
  55.7%
230
  59.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine, Tillotts Pharma AG)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Non-inferiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-10.8 to 3.0
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Period 1: Change in Mayo Score From Baseline
Hide Description

Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups.

The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician’s global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
Hide Arm/Group Description:
3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 371 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.1  (2.7) 3.2  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.3
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Period 1: Change in Partial Mayo Score From Baseline
Hide Description Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician’s global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
Hide Arm/Group Description:
3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 387 383
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.5  (2.2) 2.5  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.3 to 0.3
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Period 1: Change in Stool Frequency Score
Hide Description Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success.
Time Frame Baseline and Week 8
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Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
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3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 387 383
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (1.1) 0.9  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.455
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.2
Estimation Comments The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).
17.Secondary Outcome
Title Period 1: Change in Rectal Bleeding Score From Baseline
Hide Description Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success.
Time Frame Baseline and Week 8
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Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
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3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 387 383
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (0.8) 1.0  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.937
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.1 to 0.1
Estimation Comments The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.
18.Secondary Outcome
Title Period 1: Change in Physician Global Assessment Score From Baseline
Hide Description

Between-Group Difference of Physician Global Assessment Score, Change from Baseline.

The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.

Time Frame Baseline and Week 8
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Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
Hide Arm/Group Description:
3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 387 383
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (0.8) 0.7  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.357
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.1
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Period 1: Change in Endoscopic Score From Baseline
Hide Description Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title TP05 (Mesalazine) Asacol (Mesalazine)
Hide Arm/Group Description:
3.2g/day once daily at week 8
3.2g/d twice daily at week 8
Overall Number of Participants Analyzed 371 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (0.9) 0.6  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TP05 (Mesalazine), Asacol (Mesalazine)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.0
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Period 2: Clinical Remission
Hide Description Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Time Frame Week 16
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Intent to Treat
Arm/Group Title Extended Induction
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Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
53
  21.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended Induction
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 21.8
Confidence Interval (2-Sided) 95%
16.8 to 27.5
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Period 2: Rectal Bleeding Sub-score of 0
Hide Description Percentage of patients achieving the endpoint rectal bleeding sub-score of 0
Time Frame Week 16
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Intent to treat
Arm/Group Title Extended Induction
Hide Arm/Group Description:
Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
146
  60.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended Induction
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 60.1
Confidence Interval (2-Sided) 95%
53.6 to 66.3
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Period 2: Stool Frequency 0
Hide Description Percentage of patients achieving the endpoint stool frequency sub-score of 0
Time Frame Week 16
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Intent to Treat
Arm/Group Title Extended Induction
Hide Arm/Group Description:
Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
64
  26.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended Induction
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 26.3
Confidence Interval (2-Sided) 95%
20.9 to 32.3
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Period 2: Urgency
Hide Description Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits.
Time Frame Week 16
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Indent to Treat
Arm/Group Title Extended Induction
Hide Arm/Group Description:
Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
109
  44.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended Induction
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 44.9
Confidence Interval (2-Sided) 95%
38.5 to 51.3
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Period 2: UC-Related Complications
Hide Description Percentage of Patients Experiencing Complications related to UC
Time Frame Week 16
Hide Outcome Measure Data
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Intent to Treat
Arm/Group Title Extended Induction
Hide Arm/Group Description:
Non-responders to blinded treatment at week 8 of the induction phase (Period 1) were moved to open-label extended induction treatment of an additional 8 weeks (Period 2)
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended Induction
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
0.0 to 1.5
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Period 3: Clinical Response
Hide Description A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Time Frame Week 38
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Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participants
94.1 83.9 78.4
26.Secondary Outcome
Title Period 3: Clinical and Endoscopic Remission
Hide Description Mayo Score of <= 2 points with no individual sub-score > 1
Time Frame Week 38
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Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participants
65.8 39.4 29.6
27.Secondary Outcome
Title Period 3: Clinical and Endoscopic Response
Hide Description Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and > 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1.
Time Frame Week 38
Hide Outcome Measure Data
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Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participants
89.6 78.1 69.3
28.Secondary Outcome
Title Period 3: Endoscopic Remission
Hide Description Percentage of each dose group achieving an endoscopy sub score of 0
Time Frame Week 38
Hide Outcome Measure Data
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Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participants
37.6 32.4 13.6
29.Secondary Outcome
Title Period 3: Endoscopic Response
Hide Description Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Time Frame Week 38
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Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participants
73.8 58.8 53.3
30.Secondary Outcome
Title Period 3: Rectal Bleeding Sub Score of 0
Hide Description Percentage of each dose group achieving the endpoint rectal bleeding subscore 0
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Number
Unit of Measure: percentage of participants
88.1 76.3 74.9
31.Secondary Outcome
Title Period 3: Stool Frequency Sub-score 0
Hide Description Patients achieving a Stool Frequency sub-score of 0
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Count of Participants
Unit of Measure: Participants
148
  73.3%
101
  36.9%
66
  33.2%
32.Secondary Outcome
Title Period 3: No Urgency
Hide Description No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days.
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase ((Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Count of Participants
Unit of Measure: Participants
161
  79.7%
173
  63.1%
109
  54.8%
33.Secondary Outcome
Title Period 3: UC-Related Complications
Hide Description Percentage of Patients with Complications related to UC
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1.6g/Day Maintenance Open-Label 3.2/Day Maintenance Open-Label 4.8g/Day Maintenance Open-Label
Hide Arm/Group Description:
Remitters at week 12 of the induction phase (Period 1) received a daily dose of 1.6g in the maintenance open-labe phase (Period 3)
Responders at week 12 of the induction phase (Period 1) remaining on a daily dose of 3.2g in the maintenance phase open-label (Period 3)
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
Overall Number of Participants Analyzed 202 274 199
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.5%
2
   0.7%
1
   0.5%
Time Frame 2 years, 11 months
Adverse Event Reporting Description Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
 
Arm/Group Title TP05/TP05 Asacol/TP05 TP05 Extended Induction TP05 Asacol
Hide Arm/Group Description Double-blind Induction Phase: TP05, and Open-Label Maintenance Phase: TP05 Double-blind Induction Phase: Asacol, and Open-Label Maintenance Phase: TP05 Extended Induction only, Open-Label Double-blind Induction Phase only Double-blind Induction Phase only
All-Cause Mortality
TP05/TP05 Asacol/TP05 TP05 Extended Induction TP05 Asacol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TP05/TP05 Asacol/TP05 TP05 Extended Induction TP05 Asacol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/409 (5.87%)      18/408 (4.41%)      3/243 (1.23%)      9/409 (2.20%)      7/408 (1.72%)    
Blood and lymphatic system disorders           
Anaemia  1 [1]  2/409 (0.49%)  2 2/408 (0.49%)  2 0/243 (0.00%)  0 1/409 (0.24%)  1 1/408 (0.25%)  1
Cardiac disorders           
Hypertensive heart disease  1  1/409 (0.24%)  1 0/408 (0.00%)  0 1/243 (0.41%)  1 0/409 (0.00%)  0 0/408 (0.00%)  0
Artrial fibrilation  1  1/409 (0.24%)  1 0/408 (0.00%)  0 1/243 (0.41%)  1 0/409 (0.00%)  0 0/408 (0.00%)  0
Unstable angina  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 1/409 (0.24%)  1 0/408 (0.00%)  0
Gastrointestinal disorders           
Deterioration ulcerative colities  1  9/409 (2.20%)  10 6/408 (1.47%)  7 0/243 (0.00%)  0 4/409 (0.98%)  5 4/408 (0.98%)  4
Proctitis  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Chronic pancreatitis  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Infections and infestations           
Clostridium dificile  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 1/409 (0.24%)  1 0/408 (0.00%)  0
Chronic tonsilitis  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Flue  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 1/409 (0.24%)  1 0/408 (0.00%)  0
Pneumonia  1  1/409 (0.24%)  1 1/408 (0.25%)  1 0/243 (0.00%)  0 1/409 (0.24%)  1 1/408 (0.25%)  1
Perichondritis  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 1/408 (0.25%)  1
Injury, poisoning and procedural complications           
Ligament rupture  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Tibia fracture  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Metabolism and nutrition disorders           
Diabetes melitus  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Herniated disc  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Nervous system disorders           
Transient ischaemic attack  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Cerebral infarction  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Cerebral haematoma  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Fading fetus  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Psychiatric disorders           
Depression  1  0/409 (0.00%)  0 2/408 (0.49%)  2 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Renal and urinary disorders           
Acute heamorrhagic cystitis  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Nasal septum deformation  1  0/409 (0.00%)  0 1/408 (0.25%)  1 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Pulmonary embolism  1  0/409 (0.00%)  0 1/408 (0.25%)  1 1/243 (0.41%)  1 0/409 (0.00%)  0 0/408 (0.00%)  0
Vascular disorders           
Cryoglobulinemic vasculitis  1  1/409 (0.24%)  1 0/408 (0.00%)  0 0/243 (0.00%)  0 0/409 (0.00%)  0 0/408 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra (18.0)
[1]
Iron deficiency
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TP05/TP05 Asacol/TP05 TP05 Extended Induction TP05 Asacol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/409 (14.18%)      75/408 (18.38%)      0/243 (0.00%)      26/409 (6.36%)      22/408 (5.39%)    
Gastrointestinal disorders           
Worsening of UC  1 [1]  58/409 (14.18%)  59 75/408 (18.38%)  75 0/243 (0.00%)  0 26/409 (6.36%)  27 22/408 (5.39%)  22
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18
[1]
Symptoms of active ulcerative colitis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Robert Hofmann, MD PhD
Organization: Tillotts Pharma AG
Phone: +4161 935 27 14
Responsible Party: Tillotts Pharma AG
ClinicalTrials.gov Identifier: NCT01903252     History of Changes
Other Study ID Numbers: TP0503
First Submitted: July 9, 2013
First Posted: July 19, 2013
Results First Submitted: May 22, 2017
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018