Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Phase 3CompletedNCT00415597

Pfizer467 enrolled

Overview

Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

467

Conditions

Pain

Interventions

ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)DRUG

capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject 18-70 years of age * Subject agrees to refrain from taking any opioid medications other than study medication during study period. * History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline Exclusion Criteria: * Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated. * Subject is pregnant or breast-feeding. * Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin). * Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit. * Subject has a Body Mass Index (BMI)\>45kg/m2.

Locations (58)

Outcomes

Primary Outcomes

Subjects With Treatment Emergent Adverse Events

Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).

Time frame: up to 12 months

Secondary Outcomes

Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain

Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.

Time frame: 12 weeks

Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain

Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.

Time frame: 52 weeks

Data from ClinicalTrials.gov

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Michael Gibson, MD

Birmingham, Alabama, United States

Steven Siwek, MD

Phoenix, Arizona, United States

Michael Loes, MD

Phoenix, Arizona, United States

Allan Soo, MD

Tempe, Arizona, United States

Leah Schmidt, DO

Tucson, Arizona, United States

Steve Sitar, MD

Anaheim, California, United States

Robert Burton, MD

Anaheim, California, United States

Arturo Palencia, MD

Bakersfield, California, United States

Adam Karnes, MD

Beverly Hills, California, United States

Douglas Haselwood, MD

Fair Oaks, California, United States

...and 48 more locations