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Trial registered on ANZCTR


Registration number
ACTRN12612001012864
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
19/09/2012
Date last updated
6/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine Modified Release (MR) when Co-administered or Administered Alone in Healthy Subjects
Scientific title
A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine Modified Release (MR) when Co-administered or Administered Alone in Healthy Subjects
Secondary ID [1] 280953 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pain in Musculoskeletal disorders 287054 0
Condition category
Condition code
Musculoskeletal 287382 287382 0 0
Other muscular and skeletal disorders
Anaesthesiology 287709 287709 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment A: Co-administration of a single oral dose of etoricoxib 90mg (tablet) and tizanidine MR 6mg (capsule)

Treatment B: Administration of a single oral dose of etoricoxib 90mg (tablet) alone

Treatment C: Administration of a single oral dose of tizanidine MR 6mg (capsule) alone

All participants will receive single oral doses of each treatment in a 3 way crossover fashion with a minimum of 7 day washout period in between.

MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
Intervention code [1] 285390 0
Treatment: Drugs
Comparator / control treatment
3-Way Crossover
Control group
Active

Outcomes
Primary outcome [1] 287652 0
Outcome: The effect of co-administration of etoricoxib 90mg and tizanidine MR 6mg on the AUC 0-infinity of etoricoxib


Measured by: pharmacokinetics of etoricoxib
Timepoint [1] 287652 0
Time points (Treatment A: combination): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (2 samples collected at each time point)

Time points (Treatment B: etoricoxib): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (single sample at each time point)
Primary outcome [2] 287958 0
The effect of co-administration of etoricoxib 90mg and tizanidine MR 6mg on the AUC 0-infinity and Cmax of tizanidine

Measured by: pharmacokinetics of tizanidine
Timepoint [2] 287958 0
Time points (Treatment A: combination): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (2 samples collected at each time point)

Time points (Treatment C:tizanidine): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (single sample at each time point)
Secondary outcome [1] 298584 0
Outcome: To evaluate the effect of co-administration of etoricoxib 90mg and tizanidine MR 6mg on the pharmacokinetics of etoricoxib and tizanidine MR (e.g Tmax, and apparent t1/2 for etoricoxib and Tizanidine MR; Cmax for etoricoxib only)
Timepoint [1] 298584 0
Time points (Treatment A: combination): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (2 samples collected at each time point)

Time points (Treatment B: etoricoxib): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (single sample at each time point)

Time points (Treatment C:tizanidine): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (single sample at each time point)
Secondary outcome [2] 299127 0
To monitor the safety of subjects participating in the study and tolerability of etoricoxib 90mg and tizanidine MR 6mg when co-administered versus administered alone considering adverse events (all adverse events recorded), physical exams, vital sign measurements, 12-lead electrocardiograms, and laboratory safety tests (serum chemistry, haematology and urinalysis)

Measured by: adverse events, physical exams, vital sign measurements, 12-lead electrocardiograms, and laboratory safety tests (serum chemistry, haematology and urinalysis)
Timepoint [2] 299127 0
Time points:
Adverse events(all adverse events recorded): pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hrs post dose
Physical Exams: pre dose, 14 days post dose
Vital Signs Measurement: pre dose, 4hr, 8hr, 14 days post dose
ECG: pre dose, 14 days post dose
Lab safety tests: pre dose, 14 days post dose

Eligibility
Key inclusion criteria
-BMI < 30kg/m2
-Female of reproductive potential to have -negative pregnancy test and agree to use double-barrier contraception
-Good health based on medical history, physical examination, vital sign measurements, ECG and laboratory assessments
-Non smoker
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of emotional problems or clinically significant psychiatric disorder within 5yrs
-Clinically significant disease/disorder of any body systems
-Creatinine clearance of <80mL/min
-History of neoplastic disease
-Breast feeding mother
-History of stroke, chronic seizures or major neurological disorder
-Current use of prescription/non-prescription medication
-Consumes excessive amounts of alcohol
-Consumes excessive amounts of caffeine
-History of significant or severe allergies or anaphylactic reaction
-History of serious adverse experiences related to non-steroidal anti-inflammatory drug
-Regular user of illicit drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects randomised in the order in which they qualify for the study and given a "randomisation/allocation number". Treatment allocated based on an allocation schedule. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
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)
WA

Funding & Sponsors
Funding source category [1] 285741 0
Commercial sector/Industry
Name [1] 285741 0
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Address [1] 285741 0
One Merck Drive
Whitehouse Station, NJ, 08889-010
USA
Country [1] 285741 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Address
One Merck Drive
Whitehouse Station, NJ, 08889-010
USA
Country
United States of America
Secondary sponsor category [1] 284567 0
None
Name [1] 284567 0
Address [1] 284567 0
Country [1] 284567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287747 0
Ethics committee address [1] 287747 0
Ethics committee country [1] 287747 0
Date submitted for ethics approval [1] 287747 0
08/08/2012
Approval date [1] 287747 0
Ethics approval number [1] 287747 0

Summary
Brief summary
A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine MR when Co-administered or Administered Alone in Healthy Subjects

MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34520 0
Dr Janakan Krishnarajah
Address 34520 0
Linear Clinical Research
Level 1 B Block
Hospital Avenue
Nedlands WA 6009
Country 34520 0
Australia
Phone 34520 0
+61863825100
Fax 34520 0
Email 34520 0
jkrishnarajah@linear.org.au
Contact person for public queries
Name 17767 0
Mr Cameron Johnson
Address 17767 0
Linear Clinical Research
Level 1 B Block
Hospital Avenue
Nedlands WA 6009
Country 17767 0
Australia
Phone 17767 0
+61863825100
Fax 17767 0
Email 17767 0
cjohnson@linear.org.au
Contact person for scientific queries
Name 8695 0
Dr Janakan Krishnarajah
Address 8695 0
Linear Clinical Research
Level 1 B Block
Hospital Avenue
Nedlands WA 6009
Country 8695 0
Australia
Phone 8695 0
+61863825100
Fax 8695 0
Email 8695 0
jkrishnarajah@linear.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary