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OpenTrials
Completed

NCT Number: NCT00415597

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

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

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Key information

Conditions

Pain Arthralgia Back Pain Chronic Pain Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Michael Gibson, MD, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Embeda

Primary outcomes

  1. Subjects With Treatment Emergent Adverse Events

    Time frame: up to 12 months

    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).

Secondary outcomes

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

    Time frame: 12 weeks

    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.

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

    Time frame: 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 25, 2006
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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