Study Stopped
The study was withdrawn for administrative reason
Maxi-Analgesic Osteoarthritis (OA) Study
Maxi-Analgesic OA Study: Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 With Acetaminophen or Ibuprofen on Patients With Pain From Osteoarthritis
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo in patients who have painful osteoarthritis of the hip or knee.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 22, 2011
CompletedJanuary 6, 2016
January 1, 2016
August 16, 2011
January 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
WOMAC pain intensity VAS
The difference between the week 13 average WOMAC pain intensity VAS and the baseline WOMAC VAS
13 weeks
Secondary Outcomes (9)
Time to peak analgesic effect
13 weeks
Time-adjusted SPID
13 weeks
Difference of WOMAC stiffness score
13 weeks
Difference of WOMAC function score
13 weeks
Time to rescue medication
13 weeks
- +4 more secondary outcomes
Study Arms (4)
Maxigesic 325
ACTIVE COMPARATORMaxigesic 325 (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day, orally, with food
Acetaminophen
ACTIVE COMPARATORAcetaminophen 325 mg, three tablets four times a day, orally, with food
Ibuprofen
ACTIVE COMPARATORibuprofen 97.5mg, three tablets four times a day, orally, with food
Placebo
PLACEBO COMPARATORPlacebo tablets
Interventions
Acetaminophen 325 mg, three tablets four times a day, orally, with food
Maxigesic 325 (Acetaminophen 325 mg+ ibuprofen 97.5mg), three tablets four times a day, orally, with food
Eligibility Criteria
You may qualify if:
- Provides written informed consent before initiation of any study-related procedures.
- Have had symptoms of OA of the knee or hip for at least 6 months that has required analgesic medication.
- Have confirmed radiological evidence of OA.
- Be between 45 - 80 years of age inclusive, on the day of consent.
- In the opinion of a physician, require long term medication for treatment of painful OA.
- Have painful OA of the knee or hip with a pain score of at least 40 mm and no more than 80 mm on the WOMAC VAS pain scale at rest following a 3 - 7 day washout of existing analgesics.
You may not qualify if:
- Weigh less than 50 kg
- Rheumatoid arthritis or other inflammatory arthritis.
- Gout or recurrent episodes of pseudogout.
- Paget's disease.
- Articular fracture.
- Ochronosis.
- Acromegaly.
- Haemochromatosis.
- Wilson's Disease.
- Primary Osteochondromatosis.
- Heritable disorders (e.g. hypermobility).
- Have received or taken oral or parenteral corticosteroids within 2 months or intra-articular hyaluronic acid within 9 months.
- Has taken any single dose of an NSAID or acetaminophen within 12 hours prior to first dose of study drug
- Known to be pregnant or possibly pregnant
- Women of childbearing potential who, in the opinion of the investigator, are not using reliable contraception.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Moodie, Doctor
Clinical Trial New Zealand Ltd, 32 Kahikatea Drive, Hamilton, New Zealand
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 22, 2011
Last Updated
January 6, 2016
Record last verified: 2016-01