Chronic Pain
Conditions
Keywords
OA, Chronic Pain, Osteoarthritis, OA Pain, Osteoarthritis Pain, Pain, Hip Pain, Knee Pain, Joint Pain
Brief summary
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
Interventions
hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
DRUGPlacebo
Placebo
Sponsors
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months * Patients required daily opioid medication to treat their chronic osteoarthritis pain
Exclusion criteria
* Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain * History drug or alcohol abuse * Fibromyalgia * Patients who have major depression or anxiety * Women who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase | Baseline, Week 12 | Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated. |
Other
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Time to Treatment Failure From Baseline | within 12 weeks from Baseline |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OROS Hydromorphone OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg | 100 |
| Placebo Matching placebo tablets orally once daily | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Placebo | Total | OROS Hydromorphone |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 40 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 160 Participants | 83 Participants |
| Age, Continuous | 55.4 years STANDARD_DEVIATION 11.1 | 55.8 years STANDARD_DEVIATION 10.44 | 56.3 years STANDARD_DEVIATION 9.78 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 100 participants | 200 participants | 100 participants |
| Sex: Female, Male Female | 53 Participants | 107 Participants | 54 Participants |
| Sex: Female, Male Male | 47 Participants | 93 Participants | 46 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 | 197 / 338 | 68 / 100 | 52 / 100 |
| serious Total, serious adverse events | 6 / 338 | 5 / 100 | 1 / 100 |
Outcome results
Primary
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Time frame: Baseline, Week 12
Population: Intent to treat population defined as all patients randomized to the Double-blind phase who received at least one dose of randomized study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OROS Hydromorphone | Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase | 0.6 units on a scale | Standard Deviation 2.02 |
| Placebo | Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase | 0.6 units on a scale | Standard Deviation 1.87 |
Other Pre-specified
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase
Time frame: Baseline to Week 12
Other Pre-specified
Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase
Time frame: Baseline to Week 12
Other Pre-specified
Time to Treatment Failure From Baseline
Time frame: within 12 weeks from Baseline
Other Pre-specified
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase
Time frame: Baseline to Week 12
Other Pre-specified
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase
Time frame: Baseline to Week 12
Other Pre-specified
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase
Time frame: Baseline to Week 12