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Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis (CAMPIII)

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ClinicalTrials.gov Identifier: NCT01004185
Recruitment Status : Terminated (Pediatric enrollment very slow.)
First Posted : October 29, 2009
Results First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Intervention Drug: Asacol 400 mg
Enrollment 39
Recruitment Details Screening began on 6 Oct 2009
Pre-assignment Details There was a 30-day run-in phase for subjects continuing directly from Study 2007017.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol. Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
Period Title: Overall Study
Started 19 20
Completed 10 11
Not Completed 9 9
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             0             1
Lack of Efficacy             2             1
Sponsor Terminated Study             4             5
Withdrawal by Subject             2             1
Arm/Group Title High Dose Low Dose Total
Hide Arm/Group Description Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol. Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol. Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
13.1  (2.5) 13.2  (2.1) 13.1  (2.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
5-8 years 1 0 1
9-17 years 18 20 38
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
11
  57.9%
10
  50.0%
21
  53.8%
Male
8
  42.1%
10
  50.0%
18
  46.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Hispanic or Latino
2
  10.5%
3
  15.0%
5
  12.8%
Not Hispanic or Latino
17
  89.5%
17
  85.0%
34
  87.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.3%
0
   0.0%
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  10.5%
1
   5.0%
3
   7.7%
White
16
  84.2%
17
  85.0%
33
  84.6%
More than one race
0
   0.0%
2
  10.0%
2
   5.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
Hide Description PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
MITT subjects who took at least one dose of study medication and did not have baseline stool exam positive for C. difficile, bacterial pathogens or ova/parasites.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: percentage of participants
53.3 60
2.Secondary Outcome
Title Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
Hide Description PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Subjects who took at least one dose of study medication and did not have baseline stool examination positive for C. difficile, bacterial pathogens or ova/parasites.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: percentage of participants
60 60
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol. Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
All-Cause Mortality
High Dose Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Low Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      1/20 (5.00%)    
Blood and lymphatic system disorders     
Anaemia  1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal disorders     
Colitis Ulcerative  1  0/19 (0.00%)  1/20 (5.00%)  2
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 2%
High Dose Low Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/19 (68.42%)      11/20 (55.00%)    
Gastrointestinal disorders     
Abdominal Discomfort  1  0/19 (0.00%)  1/20 (5.00%) 
Abdominal Pain  1  1/19 (5.26%)  2/20 (10.00%) 
Abdominal Pain Upper  1  1/19 (5.26%)  0/20 (0.00%) 
Colitis Ulcerative  1  1/19 (5.26%)  1/20 (5.00%) 
Constipation  1  1/19 (5.26%)  0/20 (0.00%) 
Diarrhoea  1  1/19 (5.26%)  3/20 (15.00%) 
Dyspepsia  1  1/19 (5.26%)  0/20 (0.00%) 
Gastrooesophageal Reflux Disease  1  0/19 (0.00%)  1/20 (5.00%) 
Haematochezia  1  0/19 (0.00%)  1/20 (5.00%) 
Lip Blister  1  0/19 (0.00%)  1/20 (5.00%) 
Nausea  1  1/19 (5.26%)  1/20 (5.00%) 
Rectal Haemorrhage  1  1/19 (5.26%)  0/20 (0.00%) 
Vomiting  1  1/19 (5.26%)  2/20 (10.00%) 
Cyst  1  0/19 (0.00%)  1/20 (5.00%) 
General disorders     
Axillary Pain  1  1/19 (5.26%)  0/20 (0.00%) 
Infections and infestations     
Campylobacter Gastroenteritis  1  1/19 (5.26%)  1/20 (5.00%) 
Cellulitis Orbital  1  1/19 (5.26%)  1/20 (5.00%) 
Ear Infection  1  1/19 (5.26%)  0/20 (0.00%) 
Infectious Mononucleosis  1  1/19 (5.26%)  0/20 (0.00%) 
Nasopharyngitis  1  1/19 (5.26%)  0/20 (0.00%) 
Sinusitis  1  3/19 (15.79%)  1/20 (5.00%) 
Upper Respiratory Tract Infection  1  2/19 (10.53%)  1/20 (5.00%) 
Viral Infection  1  1/19 (5.26%)  0/20 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/19 (5.26%)  0/20 (0.00%) 
Muscle Strain  1  1/19 (5.26%)  0/20 (0.00%) 
Skin Laceration  1  0/19 (0.00%)  1/20 (5.00%) 
Investigations     
Lipase Increased  1  1/19 (5.26%)  1/20 (5.00%) 
Stool Analysis Abnormal  1  0/19 (0.00%)  1/20 (5.00%) 
Urinary Sediment Present  1  1/19 (5.26%)  0/20 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/19 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/19 (5.26%)  0/20 (0.00%) 
Pain in Extremity  1  1/19 (5.26%)  1/20 (5.00%) 
Nervous system disorders     
Headache  1  3/19 (15.79%)  1/20 (5.00%) 
Renal and urinary disorders     
Proteinuria  1  1/19 (5.26%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/19 (5.26%)  0/20 (0.00%) 
Epistaxis  1  1/19 (5.26%)  0/20 (0.00%) 
Oropharyngeal Pain  1  1/19 (5.26%)  1/20 (5.00%) 
Sinus Congestion  1  1/19 (5.26%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/19 (5.26%)  0/20 (0.00%) 
Dry Skin  1  0/19 (0.00%)  1/20 (5.00%) 
Rash  1  0/19 (0.00%)  1/20 (5.00%) 
Rash Macular  1  0/19 (0.00%)  1/20 (5.00%) 
Skin Erosion  1  0/19 (0.00%)  1/20 (5.00%) 
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: NCT01004185     History of Changes
Other Study ID Numbers: 2008085
First Submitted: October 27, 2009
First Posted: October 29, 2009
Results First Submitted: March 27, 2012
Results First Posted: May 25, 2012
Last Update Posted: May 25, 2012