Pain
Conditions
Keywords
chronic pain, joint pain, back pain, diabetic peripheral neuropathy, post herpetic neuralgia, ALO-01, Embeda, Chronic Non-Malignant Pain
Brief summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Interventions
DRUGALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject 18-70 years of age * Subject agrees to refrain from taking any opioid medications other than study medication during study period. * History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline
Exclusion criteria
* Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated. * Subject is pregnant or breast-feeding. * Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin). * Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit. * Subject has a Body Mass Index (BMI)\>45kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Treatment Emergent Adverse Events | up to 12 months | Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | 12 weeks | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. |
| Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | 52 weeks | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALO-01 | 465 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment | Protocol Violation | 1 |
| Enrollment | Withdrawal by Subject | 1 |
| Treatment | Administrative | 3 |
| Treatment | Adverse Event | 110 |
| Treatment | Drug Screen | 2 |
| Treatment | Lack of Efficacy | 39 |
| Treatment | Lost to Follow-up | 28 |
| Treatment | Multiple Reasons | 1 |
| Treatment | Physician Decision | 3 |
| Treatment | Protocol Violation | 67 |
| Treatment | Sponsor Decision | 1 |
| Treatment | Withdrawal by Subject | 51 |
Baseline characteristics
| Characteristic | ALO-01 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 417 Participants |
| Age Continuous | 51.7 years STANDARD_DEVIATION 10.56 |
| Brief Pain Inventory (BPI) Average Pain | 6.0 Units on scale STANDARD_DEVIATION 1.67 |
| Sex: Female, Male Female | 245 Participants |
| Sex: Female, Male Male | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 265 / 465 |
| serious Total, serious adverse events | 33 / 465 |
Outcome results
Primary
Subjects With Treatment Emergent Adverse Events
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
Time frame: up to 12 months
Population: Patients treated with study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALO-01 | Subjects With Treatment Emergent Adverse Events | 378 participants |
Secondary
Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
Time frame: 12 weeks
Population: Patients with data at Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-01 | Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | -31.3 Percent change | Standard Deviation 37.44 |
Comparison: Null hypothesis: Percent change from baseline = 0p-value: <0.0001t-test, 2 sided
Secondary
Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
Time frame: 52 weeks
Population: Patients with data at Week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-01 | Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | -41.5 Percent change | Standard Deviation 39.28 |
Comparison: Null hypothesis: Percent change from baseline = 0p-value: <0.0001t-test, 2 sided