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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00004288




Registration number
NCT00004288
Ethics application status
Date submitted
18/10/1999
Date registered
19/10/1999
Date last updated
24/06/2005

Titles & IDs
Public title
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
Scientific title
Secondary ID [1] 0 0
URMC-44
Secondary ID [2] 0 0
199/11716
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - olsalazine

Treatment: Drugs: olsalazine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Meets modified New York diagnostic criteria

- Active disease, i.e., morning stiffness for more than 30 minutes

- Failed or experienced nonlife-threatening reaction to prior sulfasalazine

- No significant hematologic, hepatic, or renal disease
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Government body
Name
National Center for Research Resources (NCRR)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Rochester
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
OBJECTIVES:

I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men
with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and
physiotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00004288
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Samuel H. Zwillich
Address 0 0
University of Rochester
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries