Studies for Discontinued Opioid Products
Study ID |
Study Description |
Study Treatment |
Clinical Study Results |
|---|---|---|---|
EN3202-012 |
Double-Blind, Placebo-Controlled, Parallel-Group Comparison of the Efficacy, Opioid Dose Sparing Effects and Safety of Controlled Release Oxymorphone and Placebo in Patients with Postsurgical Pain Following Knee Arthroplasty |
Oxymorphone controlled-release tablets |
|
EN3202-015 |
Double-Blind, Placebo Controlled, Parallel Group, Dose Ranging Comparison of the Efficacy and Safety of Controlled Release Oxymorphone, Controlled Release Oxycodone (OxyContin®) and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip |
Oxymorphone controlled-release tablets |
|
EN3202-016 |
Evaluation of the Efficacy and Safety of Numorphan® CR (Oxymorphone HCl Controlled Release) Relative to Placebo and OxyContin® (Oxycodone HCl Controlled Release) in Subjects with Chronic Low Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3202-017 |
Open Label, Sequential Crossover Evaluation of the Analgesic Dose Equivalence, Efficacy and Safety of Controlled-Release Oxymorphone (Numorphan® CR) Relative to Controlled-Release Oxycodone (OxyContin®) and Controlled-Release Morphine (MS Contin®) in Patients With Cancer Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3202-018 |
A Randomized, Double-Blind, Two-Period Crossover Trial Comparing the Safety and Effectiveness of Numorphan® CR (oxymorphone controlled-release tablets) and MS Contin® (morphine sulfate controlled release tablets) for the Relief of Moderate to Severe Pain in Patients with Cancer |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3202-019 |
A Randomized, Double-Blind, Two-Period Crossover Study Comparing the Efficacy, Safety and Tolerability of Numorphan® CR (Oxymorphone HCl, Controlled Release) and OxyContin® (Oxycodone HCl, Controlled Release) in Cancer Patients Who Require Chronic Opioid Treatments |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3202-020 |
A Multicenter, Open Label Extension Study to Evaluate the Long-term Safety and Effectiveness of Numorphan® CR in Patients with Chronic Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3202-021 |
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (oxymorphone HCl controlled release) in Subjects With Cancer Pain or Chronic Lower Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3202-022 |
An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® CR for the Relief of Moderate to Severe Pain in Patients with Cancer |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3202-025 |
Double-Blind, Placebo Controlled, Parallel Group, Dose Ranging Comparison of the Efficacy and Safety of Extended Release Oxymorphone and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3202-028 |
Safety and Efficacy Study of Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3202-029 |
Long-term Effectiveness and Safety Study of Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3202-031 |
Efficacy and Safety of Oxmorphone Extended Release in Opioid-Naive Patients with Chronic Low Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3202-032 |
Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Low Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3202-402 |
Study to Compare Subjective and Objective Effects of Oxymorphone Extended-Release (OPANA ER) Versus Oxycodone Controlled-Release (OxyContin) |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed |
EN3203-004 |
Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Comparison of the Analgesic Efficacy and Safety of Numorphan® IR (Oxymorphone HCl Immediate Release), Percolone, and Placebo in Patients With Postsurgical Pain Following Orthopedic Total Hip and Knee Replacement |
Oxymorphone hydrochloride immediate-release tablets |
|
EN3203-005 |
A Multicenter, Randomized, Double-Blind, Placebo and Active Controls, Single-Dose Study of Oxymorphone IR and Oxycodone IR in Patients With Pain Following Orthopedic Surgery |
Oxymorphone hydrochloride immediate-release tablets |
|
EN3203-008 |
Post-operative Knee Surgery Efficacy and Safety Study |
OPANA® (oxymorphone hydrochloride) Tablets |
Completed |
EN3203-009 |
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain |
OPANA® (oxymorphone hydrochloride) Tablets |
Completed |
EN3288-108 |
An Open-Label, Randomized, Single-Dose, Six Period, Crossover Study to Evaluate the Relative Bioavailability of EN3288 40 mg Intact and After Physical Tampering Using Various Methods Compared with OPANA® 10 mg (4 × 10 mg) in Healthy Adult Subjects |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3288-109 |
A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Crossover Study to Evaluate the Relative Bioavailability and Subjective Effects of EN3288 40 mg Administered Intact and After Manipulation Compared With OPANA® ER 40 mg Administered After Manipulation and With OPANA® 40 mg (4 × 10 mg) Administered Intact in Healthy Non-Dependent Recreational Oral Prescription Opioid Users Experienced in Manipulation of Extended-Release Opioid Formulations |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3288-113 |
A Double-blind, Dose-Ranging, Pilot Study to Evaluate the Safety, Subjective Effects, and Pharmacokinetics of Oxymorphone Hydrochloride in Healthy Subjects Who Recreationally Administer Opioids Intranasally |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3288-114 |
A Randomized Double-Blind, Single-Dose, Placebo-Controlled, Four-Period, Crossover Study to Evaluate the Subjective Effects and Systemic Exposure of Manipulated OPANA® ER Administered Intranasally Compared with Oxymorphone Hydrochloride Powder Administered Intranasally in Healthy, Non-Dependent Subjects Who Recreationally Administer Opioids Intranasally |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3288-901 |
Assessment of the ease with which experienced controlled-release prescription opioid abusers prepare a tamper-resistant formulation for intravenous use: comparison between OPANA® ER and oxymorphone HCl extended-release tamper-resistant tablets |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3288-902 |
Assessment of the ease with which experienced controlled-release prescription opioid abusers prepare a tamper-resistant formulation for intranasal use: comparison between OPANA® ER and oxymorphone HCl extended-release tamper-resistant tablets |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
EN3319-301 |
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects |
Oxymorphone hydrochloride immediate-release oral liquid |
Withdrawn |
EN3202-036 |
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Terminated |
EN3202-037 |
A Multicenter Study of the Safety, Tolerability, Effectiveness and Pharmacokinetics of Oxymorphone HCl Extended-Release Tablets in Pediatric Subjects Requiring an Around-the-Clock Opioid for an Extended Period of Time |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Suspended |
EN3203-010 |
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects |
OPANA® (oxymorphone hydrochloride) Tablets |
Completed |
EN3319-302 |
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate-Release Oral Liquid in Post Surgical Pediatric Subjects |
Oxymorphone hydrochloride immediate-release oral liquid |
Completed |
EN3319-304 |
An Open-label Single-dose and Randomized, Double-blind, Placebo-controlled Multiple-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oxymorphone HCl for Acute Moderate to Severe Postoperative Pain in Pediatric Subjects |
Oxymorphone hydrochloride immediate-release oral liquid |
Terminated |