Chronic Pain, Osteoarthritis
Conditions
Keywords
hip, knee, pain, osteoarthritis, OA, Kadian, Alpharma, naltrexone, Opioid, morphine, Embeda, ALO-01
Brief summary
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
Detailed description
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.
Interventions
DRUGALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
capsules, up to 80 mg bid
DRUGPlacebo
capsules, bid
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 21 years of age or older * Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential * Negative pregnancy test if female of childbearing potential * Subject is in general good health * Subject required treatment of joint pain within the last 90 days * Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee
Exclusion criteria
* Subject has a documented history of allergic reaction or intolerance to morphine or other opioids * Subject is pregnant or breast-feeding * Subject is receiving systemic chemotherapy * Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence * Subject has history of major depressive disorder not controlled with medication * Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA * Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD) * Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) | randomization to 12 weeks following randomization | Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALO-01 | 171 |
| Placebo | 173 |
| Total | 344 |
Baseline characteristics
| Characteristic | ALO-01 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 54.2 years STANDARD_DEVIATION 11.62 | 54.7 years STANDARD_DEVIATION 12.92 | 54.4 years STANDARD_DEVIATION 12.27 |
| Sex: Female, Male Female | 106 Participants | 95 Participants | 201 Participants |
| Sex: Female, Male Male | 65 Participants | 78 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 54 / 171 | 48 / 173 | 301 / 547 |
| serious Total, serious adverse events | 6 / 171 | 3 / 173 | 3 / 547 |
Outcome results
Primary
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
Time frame: randomization to 12 weeks following randomization
Population: intent to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-01 | Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) | -0.2 units on scale | Standard Deviation 1.94 |
| Placebo | Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) | 0.3 units on scale | Standard Deviation 2.05 |
Comparison: Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.p-value: 0.0445ANCOVA