Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000309280
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
19/05/2009
Date last updated
28/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to determine the safety, tolerability and process by which ibuprofen is absorbed, distributed, metabolized, and eliminated by the body over a 5-7 minute infusion.
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Crossover Study of the Pharmacokinetics, Safety and Tolerability of Ibuprofen Injection (IVib) in Healthy Adult Volunteers.
Universal Trial Number (UTN)
Trial acronym
(IVib) Ibuprofen Injection
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombophlebitis 4608 0
Condition category
Condition code
Inflammatory and Immune System 4907 4907 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Single dose of IVIb and Oral Placebo
1a)Single dose of active intravenous 8mL of ibuprofen in a 192mL bag of saline and Single dose of placebo oral 800mg sugar pill
2) Single dose of Oral Ibuprofen and intravenous placebo
2a) Single dose of active oral 800mg ibuprofen and Single dose of placebo intravenous 200mL of saline
Oral and Infusion to be taken concurrently over 5-7 minutes.
Intervention code [1] 4370 0
Treatment: Drugs
Comparator / control treatment
SEQUENCE A: A single dose of IVIb and oral placebo administered concurrently on Day 1 of the Treatment Period followed by a single dose of oral ibuprofen and intravenous placebo given concurrently on Day 8 of the Treatment Period.

SEQUENCE B: A single dose of oral ibuprofen and intravenous placebo
administered concurrently on Day 1 of the Treatment Period followed by a single dose of IVIb and oral placebo given concurrently on Day 8 of the Treatment Period. Days 2-7 will be a washout period.
Control group
Placebo

Outcomes
Primary outcome [1] 5754 0
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes by doing blood analysis.
Timepoint [1] 5754 0
Predose, Immediately after
completion of the intravenous Clinical Trial Material (CTM) administration then at Hours 0.25,
0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours after treatment.
Secondary outcome [1] 241706 0
To evaluate the safety and tolerability of a single dose of IVIb by assessing the
frequency, severity and duration of treatment-emergent adverse events,
including those related to the infusion site, in healthy adult participants who received a single dose of IVIb and oral placebo administration given concurrently as compared to a crossover oral ibuprofen and intravenous placebo administration. This will be done by frequently asking the volunteer non leading questions regarding there well-being, also visual observation looking for volunteer deteriation.
Adevrse Events iexamples: swelling and redness at infusion site, nausea and headache.
Timepoint [1] 241706 0
Predose, Immediately after
completion of the intravenous CTM administration then at Hours 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours after treatment.

Eligibility
Key inclusion criteria
Healthy volunteers between the ages of 18 and 65 years (at the time of consent).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants lacking good venous access in both arms.

History of allergy or hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or any component of intravenous ibuprofen.

Have never taken aspirin or ibuprofen

History of abuse of alcohol or other drugs in the 2 months before CTM administration.

Have used prescription drugs (not including oral contraceptives) within 14 days before CTM administration or have used aspirin within one week before CTM administration or over-the-counter pain relievers (NSAIDs or acetaminophen) within 3 days before CTM administration.

Have taken investigational drugs within 30 days before CTM administration.

Have donated blood or blood products within 30 days before CTM administration.

Be pregnant or nursing.

Have had breast cancer.

Have a clinically significant laboratory test

Presence or history of the following conditions: asthma, bleeding tendency, hypertension, heart failure, peptic ulcer disease, inflammatory bowel disease, or any other gastrointestinal disorder, renal or hepatic disease..

Have a calculated creatinine clearance(estimated by means of the
Cockcroft-Gault equation) of < 75mL/min

Inability to understand the requirements of the study. Participants must
be willing to provide written informed consent (as evidenced by
signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions.

Refusal to provide written authorization for use and disclosure of protected health information

Be otherwise unsuitable for the study, in the opinion of the Investigator.

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 will be enrolled into the study at the discretion of the Principal Investigator pending they meet all inclusion and exclusion criteria. By following the screening log and participant availability 12 people will be assigned a randomisation number R001-R012. This will be done by a blinded staff member.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent biostatistician will randomise the sites using simple randomisation where a randomisation table is used from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4793 0
Commercial sector/Industry
Name [1] 4793 0
Cumberland Pharmaceuticals Incorparated
Country [1] 4793 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cumberland Pharmaceuticals Incorparated
Address
2525 West End Avenue, Suite 950
Nashville, Tennessee 37203
Country
United States of America
Secondary sponsor category [1] 4327 0
None
Name [1] 4327 0
Address [1] 4327 0
Country [1] 4327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6842 0
University Of South Australia Human Research Ethics Commitee
Ethics committee address [1] 6842 0
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes SA 5095
Ethics committee country [1] 6842 0
Australia
Date submitted for ethics approval [1] 6842 0
02/02/2009
Approval date [1] 6842 0
19/03/2009
Ethics approval number [1] 6842 0
P003/09

Summary
Brief summary
This research study is being conducted for the pharmaceutical company Cumberland
Pharmaceuticals Inc. You are being asked to take part in this research study because we want to determine the safety, tolerability and pharmacokinetics (the way the body absorbs the drug) of a single dose of ibuprofen administered intravenously (in the vein) over 5-7 minutes.
A screening procedure will determine if you are eligible to enter the study. If you are
accepted, you will be required to attend the study centre for 2 treatment visits.
When you return to the research center, you will be randomised into one of two treatment sequences. Randomised means you will be assigned to a group by chance. The two treatment sequences in this study are:
Sequence A: A single dose of intravenous ibuprofen (IVIb) and an oral (capsule) placebo (starch filled capsule) given concurrently on Day 1 of the Treatment Period followed by a single dose of oral ibuprofen (capsule) and intravenous (IV) placebo (saline solution) given concurrently on Day 8 of the Treatment Period. Day 2-7will be a washout period. During the
washout period no study drugs or study tests will be done.
Sequence B: A single dose of oral ibuprofen and intravenous (IV) placebo given concurrently on Day 1 of the Treatment Period followed by a single dose of intravenous ibuprofen (IVIb) and oral placebo given concurrently on Day 8 of the Treatment Period.
Blood samples will be collected in treatment visits 1 and 2 (16 samples per visit) by either cannula (small plastic tube inserted into a vein in your arm) or venipuncture. Approximately a total of 222 mL of blood will be collected during the study, which includes the amount required for the clinical laboratory tests and for the measurement of Ibuprofen in your blood.
Trial website
http://www.cumberlandpharma.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29496 0
Address 29496 0
Country 29496 0
Phone 29496 0
Fax 29496 0
Email 29496 0
Contact person for public queries
Name 12743 0
Emma Fiddes
Address 12743 0
Centre for Pharmaceutical Research
University of South Australia
Level 2, Flexible Learning Centre
Arthur Lemon Avenue,
Underdale, SA 5032
Country 12743 0
Australia
Phone 12743 0
+618 8302 1247
Fax 12743 0
+618 8302 2930
Email 12743 0
[email protected]
Contact person for scientific queries
Name 3671 0
Associate Professor Robert Milne
Address 3671 0
Centre for Pharmaceutical Research
University of South Australia
Level 2, Flexible Learning Centre
Arthur Lemon Avenue,
Underdale, SA 5032
Country 3671 0
Australia
Phone 3671 0
+618 8302 2335
Fax 3671 0
+618 8302 2930
Email 3671 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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