Moderate-severe PainPhase 4NCT02680847

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

A Phase 4 study testing ALO-02 in people with Moderate-severe Pain, run by Pfizer at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Moderate-severe Pain
What is being tested?: ALO-02
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 16 sitesUnited States
Study dates: 21 Jan 2016to 24 Jan 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
Medical University of South Carolina, Investigational Drugs Services
Charleston, South Carolina, 29425
Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
Charleston, South Carolina, 29425
Medical University of South Carolina, SCTR Research Nexus
Charleston, South Carolina, 29425
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, 60612
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, 60612
University of Illinois Hospital at the Medical Center
Chicago, Illinois, 60612
East Carolina University Brody School of Medicine(ECU)
Greenville, North Carolina, 27834
Leo Jenkins Cancer Center Pharmacy
Greenville, North Carolina, 27834
Research Center For Clinical Studies-West, Inc.
Lancaster, California, 93534
Children's Hopsital Los Angeles
Los Angeles, California, 90027
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
Los Angeles, California, 90027
Shriners Hospitals For Children Northern California
Sacramento, California, 95817
UC Davis Health Attn: Peter Trovitch, PharmD
Sacramento, California, 95817
University of California Davis
Sacramento, California, 95817
Road Runner Research, Ltd
San Antonio, Texas, 78249

Other trials in United States

About this study

Official title: An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia

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.

Read the 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.

Conditions: Moderate-severe Pain
Being tested: ALO-02
Keywords: Pediatric, pain indication, controlled release oxycodone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALO-02Drug
Also called oxycodone hydrochloride/naltrexone hydrochloride
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.

Study groups in NCT02680847
Study group	Role	What they receive
ALO-02	Experimental	One arm, open label, active Receives: Drug: ALO-02

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 63
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.
Measured: 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)
Measured: 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 outcomes (4)

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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 77

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 201624 Jan 2018

First posted12 Feb 2016 (estimated)
Study start21 Jan 2016
Primary completion10 Jan 2018
Study completion24 Jan 2018

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Moderate-severe PainStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02680847
Sponsor's protocol ID: B4531015
Other IDs: ALO-02 PHASE 4 PEDIATRIC STUDY
Status last verified: Aug 2018
First submitted: 20 Jan 2016
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Moderate-severe Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia
ClinicalTrials.gov ID: NCT02680847
Acronym / sponsor ID: B4531015
Conditions: Moderate-severe Pain
Keywords: Pediatric, pain indication, controlled release oxycodone
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 32 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 21 Jan 2016 (actual)
Primary completion: 10 Jan 2018 (actual)
Study completion: 24 Jan 2018 (actual)
First posted: 12 Feb 2016 (estimated)
Results: Posted 25 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ALO-02	Experimental	Drug: ALO-02One arm, open label, active

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALO-02Also: oxycodone hydrochloride/naltrexone hydrochlorideOral/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.	Drug	ALO-02

Primary outcome

Average Steady-state Concentration (Css, av) of Oxycodone
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
ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Apparent Oral Clearance (CL/F) of Oxycodone
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
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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
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.
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)

4 secondary outcomes

Apparent Volume of Distribution (Vz/F) of Oxycodone
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
Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-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
Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
Time frame: Baseline up to Day 58
Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
Time frame: Baseline up to Day 77

Results and safety

Results posted to the registry on 25 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALO-02 <=20 mg	16	11
ALO-02 >20-40 mg	9	6
ALO-02 >40-80 mg	7	4

Primary outcome: Average Steady-state Concentration (Css, av) of Oxycodone

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 analysed: The PK samples were collected but not analyzed and discarded due to early termination of the study.

Primary outcome: Apparent Oral Clearance (CL/F) of Oxycodone

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 analysed: The PK samples were collected but not analyzed and discarded due to early termination of the study.

Primary outcome: Number of Participants With All-causality and Treatment-related Adverse Events (AEs)

Time frame: Baseline up to Day 63. Count of participants. Unit: Participants

Measure	ALO-02 <= 20 mg n = 16	ALO-02 >20-40 mg n = 9	ALO-02 >40-80 mg n = 7
All-causality AEs	14	8	7
Treatment-related AEs	9	6	6

Population analysed: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.

Primary outcome: Number of All-causality and Treatment-related AEs, by Intensity

Time frame: Baseline up to Day 63. Number. Unit: Events

Measure	ALO-02 <= 20 mg n = 16	ALO-02 >20-40 mg n = 9	ALO-02 >40-80 mg n = 7
All-causality AEs (mild)	38	32	26
All-causality AEs (moderate)	15	10	12
All-causality AEs (severe)	0	0	3
Treatment-related AEs (mild)	19	24	16
Treatment-related AEs (moderate)	6	4	6
Treatment-related AEs (severe)	0	0	0

Population analysed: The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 63. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALO-02 <=20 mg	0 of 16 (0%)	14 of 16 (87.5%)	0 of 16
ALO-02 >20-40 mg	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
ALO-02 >40-80 mg	2 of 7 (28.6%)	7 of 7 (100%)	0 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ALO-02 in people with Moderate-severe Pain, run by Pfizer at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Steady-state Concentration (Css, av) of Oxycodone (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02680847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.