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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR OLEPTRO


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All Clinical Trials for Oleptro

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00253890 ↗ Insomnia and Drug Relapse Risk Completed National Institute on Drug Abuse (NIDA) Phase 3 2005-10-01 The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
NCT00253890 ↗ Insomnia and Drug Relapse Risk Completed Butler Hospital Phase 3 2005-10-01 The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
NCT00775203 ↗ A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder. Completed Labopharm Inc. Phase 3 2007-06-01 The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).
NCT00839072 ↗ Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers Completed Algorithme Pharma Inc Phase 1 2009-02-01 The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
NCT00839072 ↗ Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers Completed Labopharm Inc. Phase 1 2009-02-01 The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
NCT01121900 ↗ A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) Completed Labopharm Inc. Phase 1 2008-06-01 The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.
NCT01121913 ↗ Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers Completed Labopharm Inc. Phase 1 2005-03-01 The objectives of this study were: - to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition; - to assess the controlled release properties of the two prototype formulations; - to select a prototype formulation for further development; - to validate the blood sampling schedule for future pivotal pharmacokinetic studies; - to determine the appropriate sample size for pivotal studies based in the intra-subject variability.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Oleptro

Condition Name

Condition Name for Oleptro
Intervention Trials
Healthy 3
Opiate Addiction 1
Pharmacokinetics 1
Poor Quality Sleep 1
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Condition MeSH

Condition MeSH for Oleptro
Intervention Trials
Disease 2
Depression 1
Substance-Related Disorders 1
Opioid-Related Disorders 1
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Clinical Trial Locations for Oleptro

Trials by Country

Trials by Country for Oleptro
Location Trials
United States 19
Canada 5
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Trials by US State

Trials by US State for Oleptro
Location Trials
Ohio 2
Pennsylvania 1
Illinois 1
Indiana 1
Kansas 1
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Clinical Trial Progress for Oleptro

Clinical Trial Phase

Clinical Trial Phase for Oleptro
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Oleptro
Clinical Trial Phase Trials
Completed 6
Suspended 1
Terminated 1
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Clinical Trial Sponsors for Oleptro

Sponsor Name

Sponsor Name for Oleptro
Sponsor Trials
Labopharm Inc. 5
National Institute on Drug Abuse (NIDA) 1
Butler Hospital 1
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Sponsor Type

Sponsor Type for Oleptro
Sponsor Trials
Industry 6
U.S. Fed 2
NIH 1
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