Moderate-severe Pain
Conditions
Keywords
Pediatric, pain indication, controlled release oxycodone
Brief summary
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
Detailed description
This is a multicenter, open-label, single-arm study designed to characterize the PK and to evaluate the safety of ALO-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain. The study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks. The study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose.
Interventions
DRUGALO-02
Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic. * Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \> 6 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing.
Exclusion criteria
* Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year. * Hypersensitivity to morphine, naltrexone. * A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally. * Undergone surgery within 3 days prior to the first day of dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase. | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal. A subject assessed with a COWS score\>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment. The total COWS score ranges from 0 to 48. Higher scores indicate worse outcome. Different score ranges represent different severities of withdrawal: no withdrawal (\<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (\>36) |
| Apparent Oral Clearance (CL/F) of Oxycodone | Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase | ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product. |
| Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | Baseline up to Day 63 | An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity. |
| Number of All-causality and Treatment-related AEs, by Intensity | Baseline up to Day 63 | An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity. |
| Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | Baseline up to Day 63 | An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage. |
| Average Steady-state Concentration (Css, av) of Oxycodone | Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase | ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol. | Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase | Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol. |
| Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Baseline up to Day 58 | Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate. In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) \>= 30 mmHg and diastolic blood pressure (DBP) \>=20 mmHg criteria. None of the vital sign changes were clinically significant. |
| Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Baseline up to Day 77 | Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %). Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase. None of the lab abnormalities were clinically significant. |
| Apparent Volume of Distribution (Vz/F) of Oxycodone | Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase | ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALO-02 <=20 mg Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days) | 16 |
| ALO-02 >20-40 mg Oral ALO-02 capsules average daily dose \>20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days) | 9 |
| ALO-02 >40-80 mg Oral ALO-02 capsules average daily dose \> 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days) | 7 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | No longer met eligibility criteria | 2 | 2 | 0 |
| Overall Study | Other | 2 | 0 | 0 |
| Overall Study | Unwilling to participate in study | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | ALO-02 <=20 mg | ALO-02 >20-40 mg | ALO-02 >40-80 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 13.4 years STANDARD_DEVIATION 2 | 15.2 years STANDARD_DEVIATION 1.3 | 15.3 years STANDARD_DEVIATION 1.1 | 14.0 years STANDARD_DEVIATION 2 |
| Race/Ethnicity, Customized Black | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 6 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 2 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 14 / 16 | 8 / 9 | 7 / 7 |
| serious Total, serious adverse events | 0 / 16 | 0 / 9 | 2 / 7 |
Outcome results
Primary
Apparent Oral Clearance (CL/F) of Oxycodone
ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Time frame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Population: The PK samples were collected but not analyzed and discarded due to early termination of the study.
Primary
Average Steady-state Concentration (Css, av) of Oxycodone
ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Time frame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Population: The PK samples were collected but not analyzed and discarded due to early termination of the study.
Primary
Number of All-causality and Treatment-related AEs, by Intensity
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.
Time frame: Baseline up to Day 63
Population: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 <= 20 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (moderate) | 6 Events |
| ALO-02 <= 20 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (moderate) | 15 Events |
| ALO-02 <= 20 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (severe) | 0 Events |
| ALO-02 <= 20 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (mild) | 38 Events |
| ALO-02 <= 20 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (severe) | 0 Events |
| ALO-02 <= 20 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (mild) | 19 Events |
| ALO-02 >20-40 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (mild) | 32 Events |
| ALO-02 >20-40 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (moderate) | 4 Events |
| ALO-02 >20-40 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (mild) | 24 Events |
| ALO-02 >20-40 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (severe) | 0 Events |
| ALO-02 >20-40 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (severe) | 0 Events |
| ALO-02 >20-40 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (moderate) | 10 Events |
| ALO-02 >40-80 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (severe) | 0 Events |
| ALO-02 >40-80 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (mild) | 26 Events |
| ALO-02 >40-80 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (moderate) | 12 Events |
| ALO-02 >40-80 mg | Number of All-causality and Treatment-related AEs, by Intensity | All-causality AEs (severe) | 3 Events |
| ALO-02 >40-80 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (mild) | 16 Events |
| ALO-02 >40-80 mg | Number of All-causality and Treatment-related AEs, by Intensity | Treatment-related AEs (moderate) | 6 Events |
Primary
Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.
Time frame: Baseline up to Day 63
Population: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALO-02 <= 20 mg | Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | All-causality AEs | 14 Participants |
| ALO-02 <= 20 mg | Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | Treatment-related AEs | 9 Participants |
| ALO-02 >20-40 mg | Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | All-causality AEs | 8 Participants |
| ALO-02 >20-40 mg | Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | Treatment-related AEs | 6 Participants |
| ALO-02 >40-80 mg | Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | All-causality AEs | 7 Participants |
| ALO-02 >40-80 mg | Number of Participants With All-causality and Treatment-related Adverse Events (AEs) | Treatment-related AEs | 6 Participants |
Primary
Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage.
Time frame: Baseline up to Day 63
Population: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALO-02 <= 20 mg | Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | All-causality | 0 Participants |
| ALO-02 <= 20 mg | Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | Treatment-related | 0 Participants |
| ALO-02 >20-40 mg | Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | Treatment-related | 0 Participants |
| ALO-02 >20-40 mg | Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | All-causality | 0 Participants |
| ALO-02 >40-80 mg | Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | All-causality | 2 Participants |
| ALO-02 >40-80 mg | Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) | Treatment-related | 0 Participants |
Primary
Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal. A subject assessed with a COWS score\>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment. The total COWS score ranges from 0 to 48. Higher scores indicate worse outcome. Different score ranges represent different severities of withdrawal: no withdrawal (\<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (\>36)
Time frame: Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
Population: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALO-02 <= 20 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score 5-12 (mild) (screening) | 1 Participants |
| ALO-02 <= 20 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score 5-12 (mild) (end of maintenance phase) | 1 Participants |
| ALO-02 <= 20 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score<5 (end of maintenance phase) | 15 Participants |
| ALO-02 <= 20 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score<5 (screening) | 15 Participants |
| ALO-02 >20-40 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score<5 (end of maintenance phase) | 8 Participants |
| ALO-02 >20-40 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score 5-12 (mild) (end of maintenance phase) | 1 Participants |
| ALO-02 >20-40 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score 5-12 (mild) (screening) | 0 Participants |
| ALO-02 >20-40 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score<5 (screening) | 9 Participants |
| ALO-02 >40-80 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score 5-12 (mild) (end of maintenance phase) | 0 Participants |
| ALO-02 >40-80 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score<5 (screening) | 7 Participants |
| ALO-02 >40-80 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score<5 (end of maintenance phase) | 7 Participants |
| ALO-02 >40-80 mg | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) | COWS score 5-12 (mild) (screening) | 0 Participants |
Secondary
Apparent Volume of Distribution (Vz/F) of Oxycodone
ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Time frame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Population: The PK samples were collected but not analyzed and discarded due to early termination of the study.
Secondary
Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %). Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase. None of the lab abnormalities were clinically significant.
Time frame: Baseline up to Day 77
Population: The laboratory data analysis set included only those participants who had post baseline lab results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALO-02 <= 20 mg | Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Hematology | 8 Participants |
| ALO-02 <= 20 mg | Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Chemistry | 1 Participants |
| ALO-02 >20-40 mg | Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Hematology | 5 Participants |
| ALO-02 >20-40 mg | Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Chemistry | 3 Participants |
| ALO-02 >40-80 mg | Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Hematology | 4 Participants |
| ALO-02 >40-80 mg | Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) | Chemistry | 3 Participants |
Secondary
Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate. In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) \>= 30 mmHg and diastolic blood pressure (DBP) \>=20 mmHg criteria. None of the vital sign changes were clinically significant.
Time frame: Baseline up to Day 58
Population: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALO-02 <= 20 mg | Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Maximum decrease from baseline in SBP>=30mmHg | 1 Participants |
| ALO-02 <= 20 mg | Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Maximum decrease from baseline in DBP>=20mmHg | 1 Participants |
| ALO-02 >20-40 mg | Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Maximum decrease from baseline in SBP>=30mmHg | 0 Participants |
| ALO-02 >20-40 mg | Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Maximum decrease from baseline in DBP>=20mmHg | 2 Participants |
| ALO-02 >40-80 mg | Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Maximum decrease from baseline in SBP>=30mmHg | 1 Participants |
| ALO-02 >40-80 mg | Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria | Maximum decrease from baseline in DBP>=20mmHg | 0 Participants |
Secondary
Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.
Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.
Time frame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Population: The PK samples were collected but not analyzed and discarded due to early termination of the study.