The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747
versus placebo in relieving pain in subjects with osteoarthritis of the knee.
Key Inclusion Criteria:
- be a man or woman between 18 and 75 years of age, inclusive
- for women of childbearing potential, be using an insertable, injectable, transdermal,
or combination oral contraceptive deemed highly effective by the United States Food
and Drug Administration from the first dose of study medication through the end of
the study and have negative findings on pregnancy tests performed at screening and
randomization (women who are surgically sterile [eg, hysterectomy, tubal ligation] or
postmenopausal [if ≥ 55 years old, no menses for at least 2 years; if < 55 years old,
follicle-stimulating hormone concentrations within the postmenopausal range of > 40
mIU/mL and 17 β estradiol levels of < 37 pg/mL] are also eligible to participate)
- for male subjects, be surgically sterile or agree to use an appropriate method of
contraception (ie, use a barrier method in conjunction with spermicide or have a
sexual partner who is surgically sterile, postmenopausal, or using an insertable,
injectable, transdermal, or combination oral contraceptive deemed highly effective by
the United States Food and Drug Administration) from the first dose of study
medication through the end of the study
- have a body weight between 45 and 150 kg, inclusive
- have had pain in the index knee for at least the past 6 months
- meet the following criteria for osteoarthritis of the knee established by the
American College of Rheumatology (radiographs must have been taken within the last
year; if none is available, a radiograph must be taken and the diagnostic criteria
must be confirmed before the subject is enrolled in the study): have index knee pain
plus at least 1 moderate or definite osteophyte on radiographs, as well as at least 1
of the following: be more than 50 years old, have morning stiffness for less than 30
minutes, or have crepitus on active motion
- have an average weekly pain score of at least 4. 00 on the NPRS for the index knee
during the baseline week before randomization (to be eligible for randomization,
subjects must report their NPRS score via the IVRS for at least 4 of the 7 days
immediately before randomization, with the first score being recorded on Day 6)
- if receiving nonselective or selective cyclooxygenase (COX) inhibitors, have a stable
daily dose regimen for at least 4 weeks before screening; if receiving nonselective
or selective COX inhibitors on an as needed basis, have discontinued use by Day 14;
if receiving ACE inhibitors, have a stable dose regimen for at least 4 weeks before
screening
Key Exclusion Criteria:
- have undergone arthroscopy on the index knee within 6 months before study entry
- have other severe pain that, in the opinion of the investigator, may impair the
assessment of the pain due to osteoarthritis
- have a history of hypersensitivity or intolerance to opioids (including tramadol and
tapentadol)
- have, as determined by the investigator or the sponsor's medical monitor, a history
or clinical manifestations of significant renal, hepatic, hematologic,
cardiovascular, metabolic, gastrointestinal, neurologic, psychiatric, or other
condition that would preclude participation in the study or affect the outcome of the
study
- have taken oral or intramuscular corticosteroids within 30 days before study entry
(inhaled or topical corticosteroids are permitted)
- have received intra articular injections of corticosteroids into the index joint
within 12 weeks before screening
- have received intra articular injections of hyaluronic acid into the index joint
within 24 weeks before screening
- be currently taking medications other than nonsteroidal anti inflammatory drugs
prescribed for chronic pain (such as duloxetine or pregabalin)
Marylou Sirotnak, RN, CCRC, Phone: 281-360-5888, Email: Marylou.Sirotnak@Premier-Research.com
