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Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT00713310
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : April 4, 2012
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Intervention Drug: Asacol 400 mg
Enrollment 83
Recruitment Details Recruitment began 16 Dec 2008
Pre-assignment Details  
Arm/Group Title Low-Dose High-Dose
Hide Arm/Group Description 17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo 17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
Period Title: Overall Study
Started 41 42
mITT Population 41 41 [1]
Completed 36 36
Not Completed 5 6
Reason Not Completed
Adverse Event             5             2
Lack of Efficacy             0             2
Withdrawal by Subject             0             2
[1]
1 subject randomized to high dose not dosed so not included in the mITT population.
Arm/Group Title Low-Dose High-Dose Total
Hide Arm/Group Description 17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo 17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg Total of all reporting groups
Overall Number of Baseline Participants 41 42 83
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 42 participants 83 participants
13.0  (3.2) 12.8  (3.0) 12.9  (3.1)
[1]
Measure Description: mITT Population
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
5-8 years 4 4 8
9-17 years 37 38 75
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Female
22
  53.7%
23
  54.8%
45
  54.2%
Male
19
  46.3%
19
  45.2%
38
  45.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
United States 26 23 49
Canada 0 4 4
Poland 9 10 19
Romania 2 3 5
Croatia 4 2 6
1.Primary Outcome
Title Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
Hide Description PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
miTT includes subjects who were randomized and took at least one dose of study medication
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description:
Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: % participants with treatment success
56.1 55.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose, High Dose
Comments A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9240
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter High-Low Dose Difference Success Rates
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-22.7 to 20.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
Hide Description PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT subjects who were randomized & took at least one dose of study medication
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description:
Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: % participants with treatment success
56.1 57.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose, High Dose
Comments A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8193
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter High-Low Dose Difference Success Rates
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-20.2 to 23.0
Estimation Comments [Not Specified]
Time Frame Day -7 thru Week 6 of trial (7 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate) High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
All-Cause Mortality
Low Dose High Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/41 (12.20%)      2/41 (4.88%)    
Blood and lymphatic system disorders     
Anaemia  1  0/41 (0.00%)  0 1/41 (2.44%)  1
Gastrointestinal disorders     
Abdominal Pain  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Colitis Ulcerative  1  1/41 (2.44%)  1 1/41 (2.44%)  1
Diarrhoea Haemorrhagic  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Pancreatitis  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Hepatobiliary disorders     
Cholangitis Sclerosing  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Infections and infestations     
Sinusitis  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Adenovirus Infection  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Investigations     
Body Mass Index Decreased  1  1/41 (2.44%)  1 0/41 (0.00%)  0
Nervous system disorders     
Syncope  1  0/41 (0.00%)  0 1/41 (2.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/50 (40.00%)      15/41 (36.59%)    
Gastrointestinal disorders     
Colitis Ulcerative  1  5/50 (10.00%)  5 2/41 (4.88%)  2
General disorders     
Fatigue  1  1/50 (2.00%)  1 3/41 (7.32%)  3
Pyrexia  1  0/50 (0.00%)  0 3/41 (7.32%)  3
Infections and infestations     
Nasopharyngitis  1  4/50 (8.00%)  4 4/41 (9.76%)  4
Sinusitis  1  3/50 (6.00%)  3 0/41 (0.00%)  0
Nervous system disorders     
Dizziness  1  3/50 (6.00%)  3 1/41 (2.44%)  1
Headache  1  4/50 (8.00%)  4 2/41 (4.88%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00713310     History of Changes
Other Study ID Numbers: 2007017
First Submitted: July 9, 2008
First Posted: July 11, 2008
Results First Submitted: March 6, 2012
Results First Posted: April 4, 2012
Last Update Posted: April 5, 2012