Open Label Extension Study to Protocol C2/13/DR-6MP-02 (OLE)
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ClinicalTrials.gov Identifier: NCT01433432 |
Recruitment Status
:
Withdrawn
(Sponsor withdrew support for study due to reorganization and project prioritization)
First Posted
: September 14, 2011
Last Update Posted
: March 7, 2013
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 12, 2011 | ||||||
First Posted Date ICMJE | September 14, 2011 | ||||||
Last Update Posted Date | March 7, 2013 | ||||||
Study Start Date ICMJE | October 2011 | ||||||
Estimated Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Maintenance of or reduction in CDAI score [ Time Frame: 12 weeks ] Maintenance of or reduction in CDAI score at week 12X (end of extension study) relative to extension study start
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01433432 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
Maintenance of or improvement in safety assessments [ Time Frame: 12 weeks ] Evaluate and compare the incidence, frequency and severity of Adverse Events between the 2 groups (those who previously received 80 mg DR6MP and continue to receive it vs. those who previously received Purinethol (1-1.5 mg/kg) and are now introduced to 80 mg DR6MP) over 12 weeks. This includes all Adverse Events reported, as well as changes in body weight and changes in clinically significant laboratory values, specifically, WBC, ALT, AST, direct and total bilirubin. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Open Label Extension Study to Protocol C2/13/DR-6MP-02 | ||||||
Official Title ICMJE | Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension Study | ||||||
Brief Summary | The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD) therapy is aimed at reducing inflammation via induction of remission after a flare-up and maintenance of the remission for as long as possible. The questions being asked in this extension study are:
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Detailed Description | By following the 2 groups of subjects, i.e, those who originally received the test formulation (80 mg DR-6MP) and are now continuing for another 12 weeks on test drug vs. those who received the reference drug (Purinethol, 1-1.5 mg/kg daily) and are now being introduced to 12 weeks of 80 mg DR6MP test drug, and monitoring the CDAI scores, immunology parameters (ex. ESR and CRP) and safety assessments (i.e., adverse events occurrences, weight changes, laboratory test results) and comparing to the parameters at extension study start, the study will effectively answer the following questions:
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Crohn's Disease | ||||||
Intervention ICMJE | Drug: 80 mg DR-6MP
All subjects from the original study, Protocol C2/13/DR-6MP-02, whether they received test drug for 12 weeks or Purinethol for 12 weeks, will now receive an additional 12 weeks of 80 mg DR-6MP drug to be administered as 2 x 40 mg DR-6MP test tablets, once nightly, before bedtime. |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE |
0 | ||||||
Original Estimated Enrollment ICMJE |
60 | ||||||
Estimated Study Completion Date | August 2012 | ||||||
Estimated Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | Israel | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01433432 | ||||||
Other Study ID Numbers ICMJE | C2/13/DR-6MP-02 EXT | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Teva GTC | ||||||
Study Sponsor ICMJE | Teva GTC | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Teva GTC | ||||||
Verification Date | March 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |