Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ALO-02 PHASE 4 PEDIATRIC STUDY | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
The trial was terminated on 08FEB2018. Pfizer has decided to withdraw the New Drug Application and has notified FDA. There are no efficacy or safety concerns.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALO-02 | Experimental | One arm, open label, active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALO-02 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| 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. | 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 |
| 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. | Baseline up to Day 63 |
| 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. | Baseline up to Day 63 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center For Clinical Studies-West, Inc. | Lancaster | California | 93534 | United States | ||
| Children's Hopsital Los Angeles |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | ALO-02 >20-40 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2006 | Jul 10, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | Baseline up to Day 63 |
| 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) | 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. |
| 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. | 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 |
| 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. | Baseline up to Day 58 |
| 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. | Baseline up to Day 77 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine | Los Angeles | California | 90027 | United States |
| Shriners Hospitals For Children Northern California | Sacramento | California | 95817 | United States |
| UC Davis Health Attn: Peter Trovitch, PharmD | Sacramento | California | 95817 | United States |
| University of California Davis | Sacramento | California | 95817 | United States |
| University of Illinois at Chicago Clinical Research Center | Chicago | Illinois | 60612 | United States |
| University of Illinois Hospital and Health Sciences Systems | Chicago | Illinois | 60612 | United States |
| University of Illinois Hospital at the Medical Center | Chicago | Illinois | 60612 | United States |
| East Carolina University Brody School of Medicine(ECU) | Greenville | North Carolina | 27834 | United States |
| Leo Jenkins Cancer Center Pharmacy | Greenville | North Carolina | 27834 | United States |
| Medical University of South Carolina Children's Hospital | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina, Investigational Drugs Services | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina, Rutledge Tower, Pediatric Clinic | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina, SCTR Research Nexus | Charleston | South Carolina | 29425 | United States |
| Road Runner Research, Ltd | San Antonio | Texas | 78249 | United States |
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)
| FG002 | 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) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population included all participants in the treatment period (including titration phase and maintenance phase) who received at least 1 dose of ALO-02. This study was single-arm and data was reported by 3 arms to show dose related differences. The results were combined, not separated by 2 phases, due to study termination.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The PK samples were collected but not analyzed and discarded due to early termination of the study. | Posted | 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 |
|
| |||||||||||||||||||||||||
| 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. | The PK samples were collected but not analyzed and discarded due to early termination of the study. | Posted | 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 |
| ||||||||||||||||||||||||||
| 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. | The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02. | Posted | Count of Participants | Participants | Baseline up to Day 63 |
| ||||||||||||||||||||||||
| 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. | The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02. | Posted | Number | Events | Baseline up to Day 63 |
| ||||||||||||||||||||||||
| 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. | The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02. | Posted | Count of Participants | Participants | Baseline up to Day 63 |
| ||||||||||||||||||||||||
| 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) | The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02. | Posted | Count of Participants | Participants | 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. |
| ||||||||||||||||||||||||
| 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. | The PK samples were collected but not analyzed and discarded due to early termination of the study. | Posted | 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 |
| ||||||||||||||||||||||||||
| 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. | The PK samples were collected but not analyzed and discarded due to early termination of the study. | Posted | 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 |
| ||||||||||||||||||||||||||
| 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. | The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02. | Posted | Count of Participants | Participants | Baseline up to Day 58 |
| ||||||||||||||||||||||||
| 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. | The laboratory data analysis set included only those participants who had post baseline lab results. | Posted | Count of Participants | Participants | Baseline up to Day 77 |
|
Baseline up to Day 63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 16 | 0 | 16 | 14 | 16 |
| EG001 | 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) | 0 | 9 | 0 | 9 | 8 | 9 |
| EG002 | 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) | 0 | 7 | 2 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Miosis | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 20.1 | Non-systematic Assessment | This event occurred on Study Day -2 and should be included in medical history instead of AE section. The error was not identified until after database lock. |
|
| Hepatic enzyme increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Social anxiety disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
The study was terminated due to sponsor's decision instead of safety or efficacy reasons. Early termination led to small numbers of participants summarized or described and PK samples were not analyzed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2015 | Jul 10, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000608978 | oxycodone naltrexone combination |
| D010098 | Oxycodone |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
Not provided
Not provided
| Male |
|
| Black |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
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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) |
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| 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) |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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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) |
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|