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

Last updated on October 10, 2018

FOR MORE INFORMATION
Study Location
Research Center For Clinical Studies-West, Inc.
Lancaster, California, 93534 United States
Contact
1-800-718-1021
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
Treatment: Up to 9 weeks
Screening: Up to 2 weeks
Site Visits
Follow up: Up to 1 visits
Treatment: Up to 7 visits
Screening: 1 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
NCT02680847
Pfizer
Terminated
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain

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Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
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.
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.
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Treatment
Moderate-severe Pain
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
Experimental: ALO-02
One arm, open label, active
Intervention: Drug: ALO-02
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
January 20, 2019
January 20, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
Puerto Rico
 
NCT02680847
B4531015
ALO-02 PHASE 4 PEDIATRIC STUDY ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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