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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415597

ALO-KNT-302

Details and patient eligibility

About

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

Enrollment: 467 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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467 participants in 1 patient group

ALO-01

Experimental group

Description:

Doses given once or twice daily

Treatment:

Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)