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High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

This study has been terminated.
(Efforts at recruitment have halted as recruitment was poor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00495521
First Posted: July 3, 2007
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacobus Pharmaceutical
Results First Submitted: June 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Drug: 4-Aminosalicylic acid extended release granules

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was open to eligible patients under the care of or referred to investigators at 5 different academic medical centers from July 2007 through October 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Recruitment was slow with only 2 patients entered.

Reporting Groups
  Description
Active Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
Placebo Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks

Participant Flow:   Overall Study
    Active   Placebo
STARTED   1   1 
COMPLETED   1   0 
NOT COMPLETED   0   1 
Physician Decision                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
4-Aminosalicylic Acid Extended Release Granules Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
Placebo Granules Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
Total Total of all reporting groups

Baseline Measures
   4-Aminosalicylic Acid Extended Release Granules   Placebo Granules   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Years]
Mean (Full Range)
 12 
 (12 to 12) 
 14 
 (14 to 14) 
 13 
 (12 to 14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      1 100.0%      1 100.0%      2 100.0% 


  Outcome Measures
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1.  Primary:   Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline   [ Time Frame: 4 weeks ]

2.  Secondary:   Rate of Remission   [ Time Frame: 4 weeks ]

3.  Secondary:   Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks   [ Time Frame: 4 weeks ]

4.  Secondary:   Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks   [ Time Frame: 4 weeks ]

5.  Secondary:   Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary   [ Time Frame: up to 4 weeks ]

6.  Secondary:   Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks   [ Time Frame: 4 weeks ]

7.  Secondary:   Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks   [ Time Frame: 4 weeks ]

8.  Secondary:   Change in IMPACT-III From Baseline to 4 Weeks   [ Time Frame: 4 weeks ]

9.  Secondary:   Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary   [ Time Frame: 4 weeks ]

10.  Secondary:   Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance   [ Time Frame: up to 4 weeks ]

11.  Secondary:   Time to Normalization of All Other Components in the Diary   [ Time Frame: up to 4 weeks ]

12.  Secondary:   Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization   [ Time Frame: 2 weeks and 4 weeks ]

13.  Secondary:   Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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. Kathy Aleš, Medical Director
Organization: Jacobus Pharmaceutical Company, Inc.
phone: 609-921-7448 ext 238
e-mail: kathy.ales@jacobus-pharmaceutical.com



Responsible Party: Jacobus Pharmaceutical
ClinicalTrials.gov Identifier: NCT00495521     History of Changes
Other Study ID Numbers: PASER - AFC.002
First Submitted: June 29, 2007
First Posted: July 3, 2007
Results First Submitted: June 5, 2017
Results First Posted: September 21, 2017
Last Update Posted: September 21, 2017