MedTrace Logo

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

NCT00415597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2013-09-20

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

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

Sponsors & Collaborators

Principal Investigators

  • James B. Jones, MD, PharmD · Alpharma Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00415597 on ClinicalTrials.gov