CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 81 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
intact ALO-02 60 mg/7.2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01746901
NCT01746901Phase 1Completed
CompareCT.gov

A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-dose, 6-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules) Compared To Oxycodone Immediate Release And Placebo When Administered Orally To Nondependent,Recreational Opioid Users.

Pfizer·interventional·Posted Dec 11, 2012·Updated Oct 19, 2018

In Brief

A Phase 1 clinical trial evaluating Placebo, intact ALO-02 60 mg/7.2 mg, and 4 other interventions for Healthy. Completed, enrolled 81 participants across 1 site.

Detailed Summary

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
CollaboratorsSyneos Health

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2012
Enrollment StartFeb 1, 2013
Primary CompletionAug 9, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.6 years ago

Interventions

Placebodrug

Placebo solution + Placebo ALO-02 (intact)

intact ALO-02 60 mg/7.2 mgdrug

Placebo solution + ALO-02 60 mg/7.2 mg (intact)

crushed ALO-02 60 mg/7.2 mgdrug

crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)

crushed oxycodone IR 60 mgdrug

crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)

crushed ALO-02 40 mg/4.8 mgdrug

crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)

crushed oxycodone IR 40 mgdrug

crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)