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Dose Escalation and Remission (DEAR) (DEAR)

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ClinicalTrials.gov Identifier: NCT00652145
Recruitment Status : Completed
First Posted : April 3, 2008
Results First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Shire
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Ulcerative Colitis
Intervention Drug: mesalamine
Enrollment 119
Recruitment Details We screened 150 patients and enrolled 119 patients with UC in remission on the basis of SCCAI score. 58 patients had baseline fecal calprotectin(FC) <50 µg/g. These patients were followed in an observational arm. 61 had FC >= 50 µg/g,whose current mesalamine dose <3g/day. See preassignment details.
Pre-assignment Details Among 61 pts with FC >=50 µg/g at week 0, 26 were taking non-MMX mesalamine at baseline and switched to MMX mesalamine 2.4g/day. Of these, by week 6, 2 had a repeat FC <50 µg/g, 3 had a flare of UC and 4 were noncompliant with study protocol or no longer interested in participating. The remaining 52 patients were included in the randomized trial.
Arm/Group Title Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Hide Arm/Group Description Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks Maintain baseline mesalamine dose for six weeks
Period Title: Overall Study
Started 26 26
Completed 26 26
Not Completed 0 0
Arm/Group Title Increase Mesalamine Dose Maintain Mesalamine Dose Total
Hide Arm/Group Description Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose Participants were randomized to maintain their baseline mesalamine dose Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
43.8
(30.5 to 57.1)
48.8
(33.5 to 60.4)
46.5
(32.0 to 58.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
11
  42.3%
13
  50.0%
24
  46.2%
Male
15
  57.7%
13
  50.0%
28
  53.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
American Indian or Alaska Native
1
   3.8%
0
   0.0%
1
   1.9%
Asian
1
   3.8%
0
   0.0%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   7.7%
4
  15.4%
6
  11.5%
White
22
  84.6%
21
  80.8%
43
  82.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.8%
1
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 26 participants 52 participants
26 26 52
Tobacco use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Current 0 2 2
Prior 6 8 14
Never 20 16 36
Extent of disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Proctitis 8 2 10
Left-sided 9 12 21
Extensive 9 11 20
Other 0 1 1
Median duration of UC  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
11.9
(3.7 to 19.8)
6.5
(2.2 to 11.9)
8.9
(2.8 to 15.9)
Median of duration of remission at baseline  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
0.3
(0.2 to 1.0)
0.5
(0.2 to 1.1)
0.4
(0.2 to 1.0)
Median fecal calprotectin immediately before randomization  
Median (Inter-Quartile Range)
Unit of measure:  µg/g
Number Analyzed 26 participants 26 participants 52 participants
174
(67.0 to 439)
214
(80.0 to 439)
195
(69 to 461)
Currrent oral mesalamine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Non-MMX formulation 8 9 17
MMX formulation 14 12 26
None 4 5 9
Current rectal mesalamine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Yes 2 2 4
No 24 24 48
Current thiopurine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Yes 6 4 10
No 20 22 42
Prior corticosteroids  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Yes 11 17 28
No 15 9 24
Prior rectal corticosteroids  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Yes 6 7 13
No 20 19 39
Prior cyclosporine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Yes 0 1 1
No 26 25 51
Prior anti-tumor necrosis factor agent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Yes 2 0 2
No 24 26 50
1.Primary Outcome
Title Fecal Calprotectin Level <50µg/g
Hide Description [Not Specified]
Time Frame 6 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Increase Mesalamine Dose by 2.4g/Day Maintain Mesalmine Dose
Hide Arm/Group Description:

Increase dose of mesalamine by 2.4 gm per day

mesalamine: Increase dose by 2.4gm per day over baseline dose

Maintain current mesalamine dose at 2.4 g/day
Overall Number of Participants Analyzed 26 26
Measure Type: Number
Unit of Measure: participants
7 1
2.Secondary Outcome
Title Fecal Calprotectin Level <100 µg/g
Hide Description [Not Specified]
Time Frame at 6 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
38 participants with baseline FC>=100ug/g
Arm/Group Title Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Hide Arm/Group Description:
Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
Maintain baseline mesalamine dose for six weeks
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: participants
10 3
3.Secondary Outcome
Title Fecal Calprotectin <200 µg/g
Hide Description [Not Specified]
Time Frame at 6 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
25 participants with baseline FC>=200ug/g
Arm/Group Title Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Hide Arm/Group Description:
Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
Maintain baseline mesalamine dose for six weeks
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: participants
10 2
Time Frame [Not Specified]
Adverse Event Reporting Description

Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days:

Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis

 
Arm/Group Title Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Hide Arm/Group Description Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks Maintain baseline mesalamine dose for six weeks
All-Cause Mortality
Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Increase Dose of Mesalamine Maintain Baseline Mesalamine Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/26 (42.31%)      7/26 (26.92%)    
Blood and lymphatic system disorders     
iron deficiency anemia   1/26 (3.85%)  1 0/26 (0.00%)  0
Cardiac disorders     
Palpitations   1/26 (3.85%)  1 0/26 (0.00%)  0
Eye disorders     
itchy eyes   1/26 (3.85%)  1 0/26 (0.00%)  0
Dry eyes   0/26 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders     
Abdominal pain   0/26 (0.00%)  0 1/26 (3.85%)  1
blood in stool   1/26 (3.85%)  1 2/26 (7.69%)  2
Constipation   0/26 (0.00%)  0 1/26 (3.85%)  1
diarrhea   3/26 (11.54%)  3 1/26 (3.85%)  1
Bloating   2/26 (7.69%)  2 0/26 (0.00%)  0
Flatulence   1/26 (3.85%)  1 1/26 (3.85%)  1
Worsening Colitis   1/26 (3.85%)  1 0/26 (0.00%)  0
increase mucous   0/26 (0.00%)  0 1/26 (3.85%)  1
General disorders     
dizziness   1/26 (3.85%)  1 0/26 (0.00%)  0
Fatigue   1/26 (3.85%)  1 0/26 (0.00%)  0
headache   1/26 (3.85%)  1 0/26 (0.00%)  0
Vitamin B12 deficiency   1/26 (3.85%)  1 0/26 (0.00%)  0
Lower back pain   0/26 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations     
Fever   1/26 (3.85%)  1 0/26 (0.00%)  0
Fungal infection   1/26 (3.85%)  1 0/26 (0.00%)  0
Upper respiratory infection   1/26 (3.85%)  1 1/26 (3.85%)  1
Urinary tract infection   1/26 (3.85%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
acne   0/26 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
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: James D. Lewis, MD, MSCE
Organization: University of Pennsylvania
Phone: 215-573-5137
Responsible Party: James Lewis, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00652145     History of Changes
Other Study ID Numbers: K24DK078228 ( U.S. NIH Grant/Contract )
K24DK078228 ( U.S. NIH Grant/Contract )
First Submitted: April 1, 2008
First Posted: April 3, 2008
Results First Submitted: December 1, 2014
Results First Posted: May 5, 2015
Last Update Posted: May 5, 2015