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

Pfizer logo

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)

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)

Trial contacts and locations

58

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Data sourced from clinicaltrials.gov

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