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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/NCT00992381
Registration number
NCT00992381
Ethics application status
Date submitted
8/10/2009
Date registered
9/10/2009
Date last updated
18/01/2010
Titles & IDs
Public title
Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
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Scientific title
A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn® Containing Naproxen 500 mg)
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Secondary ID [1]
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D1120C00035
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PN400
Treatment: Drugs - Naprosyn
Experimental: 1 - PN400
Active Comparator: 2 - Naproxen
Treatment: Drugs: PN400
500mg Naproxen and 20mg esomeprazole
Treatment: Drugs: Naprosyn
500mg Naproxen
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet
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Assessment method [1]
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Timepoint [1]
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blood samples taken at various time points over 2 treatment periods of 11 days
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Secondary outcome [1]
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To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,
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Assessment method [1]
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Timepoint [1]
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Blood samples taken at various time point over 2 periods of 2 days
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Secondary outcome [2]
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Compare the adverse event profile of PN 400 with that from Naprosyn®
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Assessment method [2]
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Timepoint [2]
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Adverse event reporting over 2 periods of 11 days
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Eligibility
Key inclusion criteria
- Subjects must have a body weight greater than 50 kg and BMI within the range
18-30(inclusive).
- Subjects must be in good health, as assessed during pre-study medical examination and
by review of screening results
- Subjects must understand the procedures involved and agree to participate in the study
by giving fully informed, written consent
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Significant intercurrent disease of any type, in particular liver, kidney,
cardiovascular disease, any form of diabetes or significant gastrointestinal disorder
which could affect drug absorption, or any history of gastric or duodenal ulceration.
- Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the
recruitment interview, such that these drugs will have been ingested in the 4 weeks
prior to the day set for the first Period 1 dose
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2009
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Research Site - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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POZEN
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether the absorption of naproxen from the PN 400
combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets
(Naprosyn®), which are currently sold in Australia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00992381
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Terry Hurst
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Address
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Q-Pharm Phase one unit
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00992381
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