Trial Outcomes & Findings for Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain (NCT NCT02680847)

Last Updated: 2018-09-25

Results Overview

ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

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

Results posted on

2018-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)	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)
Overall Study STARTED	16	9	7
Overall Study COMPLETED	11	6	4
Overall Study NOT COMPLETED	5	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	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)	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)
Overall Study Other	2	0	0
Overall Study No longer met eligibility criteria	2	2	0
Overall Study Unwilling to participate in study	1	1	0
Overall Study Lack of Efficacy	0	0	2
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALO-02 <=20 mg n=16 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)	Total n=32 Participants Total of all reporting groups
Age, Continuous	13.4 years STANDARD_DEVIATION 2.0 • n=5 Participants	15.2 years STANDARD_DEVIATION 1.3 • n=7 Participants	15.3 years STANDARD_DEVIATION 1.1 • n=5 Participants	14.0 years STANDARD_DEVIATION 2.0 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ALO-02 <= 20 mg n=16 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)
Number of Participants With All-causality and Treatment-related Adverse Events (AEs) All-causality AEs	14 Participants	8 Participants	7 Participants
Number of Participants With All-causality and Treatment-related Adverse Events (AEs) Treatment-related AEs	9 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ALO-02 <= 20 mg n=16 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)
Number of All-causality and Treatment-related AEs, by Intensity All-causality AEs (mild)	38 Events	32 Events	26 Events
Number of All-causality and Treatment-related AEs, by Intensity All-causality AEs (moderate)	15 Events	10 Events	12 Events
Number of All-causality and Treatment-related AEs, by Intensity All-causality AEs (severe)	0 Events	0 Events	3 Events
Number of All-causality and Treatment-related AEs, by Intensity Treatment-related AEs (mild)	19 Events	24 Events	16 Events
Number of All-causality and Treatment-related AEs, by Intensity Treatment-related AEs (moderate)	6 Events	4 Events	6 Events
Number of All-causality and Treatment-related AEs, by Intensity Treatment-related AEs (severe)	0 Events	0 Events	0 Events

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ALO-02 <= 20 mg n=16 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)
Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) All-causality	0 Participants	0 Participants	2 Participants
Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) Treatment-related	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	ALO-02 <= 20 mg n=16 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)
Number of Participants With Clinical Opiate Withdrawal Scale (COWS) COWS score<5 (screening)	15 Participants	9 Participants	7 Participants
Number of Participants With Clinical Opiate Withdrawal Scale (COWS) COWS score 5-12 (mild) (end of maintenance phase)	1 Participants	1 Participants	0 Participants
Number of Participants With Clinical Opiate Withdrawal Scale (COWS) COWS score 5-12 (mild) (screening)	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Opiate Withdrawal Scale (COWS) COWS score<5 (end of maintenance phase)	15 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ALO-02 <= 20 mg n=16 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)
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	2 Participants	0 Participants
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	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 77

Population: The laboratory data analysis set included only those participants who had post baseline lab results.

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.

Outcome measures

Outcome measures
Measure	ALO-02 <= 20 mg n=15 Participants 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)	ALO-02 >20-40 mg n=9 Participants 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)	ALO-02 >40-80 mg n=7 Participants 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)
Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) Hematology	8 Participants	5 Participants	4 Participants
Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) Chemistry	1 Participants	3 Participants	3 Participants

Adverse Events

ALO-02 <=20 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ALO-02 >20-40 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

ALO-02 >40-80 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ALO-02 <=20 mg n=16 participants at risk 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)	ALO-02 >20-40 mg n=9 participants at risk 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)	ALO-02 >40-80 mg n=7 participants at risk 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)
Nervous system disorders Migraine	0.00% 0/16 • 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.	0.00% 0/9 • 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.	14.3% 1/7 • 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.
Nervous system disorders Seizure	0.00% 0/16 • 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.	0.00% 0/9 • 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.	14.3% 1/7 • 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.
Psychiatric disorders Suicidal ideation	0.00% 0/16 • 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.	0.00% 0/9 • 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.	14.3% 1/7 • 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.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER