Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain

NCT02680847

Last updated date
Study Location
Research Center For Clinical Studies-West, Inc.
Lancaster, California, 93534, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate-severe Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid.

- Be an experienced opioid user, equivalent or equal to >20 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Allergy to oxycodone, naltrexone.


- Cannot have a life expectancy of less than 6 months.


- Is not able to take medication orally.


- Undergone surgery within 3 days prior to the first day of dosing.


- Cannot be pregnant or attempting pregnancy.


- Cannot have a positive urine test for illicit drugs.


- Any planned surgery during the course of the study.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Capsules
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: 1 weeks
Screening: Up to 2 weeks
Treatment: Up to 9 weeks
Site Visits
Follow up: Up to 1 visits
Screening: 1 visits
Treatment: Up to 7 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Electrocardiogram (ECG)
Physical examination
Questionnaire
Urine test
Vital signs and measurements
Keeping a diary

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[email protected]

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Moderate-severe PainOpen-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain
NCT02680847
  1. Lancaster, California
  2. Los Angeles, California
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  4. Sacramento, California
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  7. Chicago, Illinois
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  10. Greenville, North Carolina
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Moderate-severe PainOpen-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain
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  2. Anaheim, California
  3. Irvine, California
  4. Lancaster, California
  5. Los Angeles, California
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  9. Gainesville, Florida
  10. Gainesville, Florida
  11. Miami Lakes, Florida
  12. Miami, Florida
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  17. Chicago, Illinois
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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Moderate-severe Pain
Intervention  ICMJE Drug: ALO-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.
Other Name: oxycodone hydrochloride/naltrexone hydrochloride
Study Arms  ICMJE Experimental: ALO-02
One arm, open label, active
Intervention: Drug: ALO-02
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2016)
140
Actual Study Completion Date  ICMJE January 24, 2018
Actual Primary Completion Date January 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT02680847
Other Study ID Numbers  ICMJE B4531015
ALO-02 PHASE 4 PEDIATRIC STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP