Phase 3 Completed N=467 Treatment

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

Postoperative Pain

Source: ClinicalTrials.gov NCT00415597 ↗

Enrolled (actual)

467

Serious AEs

7.1%

Results posted

Oct 2009

Primary outcomePrimary: Subjects With Treatment Emergent Adverse Events — 378 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects With Treatment Emergent Adverse Events	378	—
SECONDARY Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain	-31.3	<0.0001 sig
SECONDARY Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain	-41.5	<0.0001 sig

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00415597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.