Phase 3 Completed N=547 Randomized Double-blind Treatment

A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

Osteoarthritis · Postoperative Pain

Source: ClinicalTrials.gov NCT00420992 ↗

Enrolled (actual)

547

Serious AEs

1.4%

Results posted

Oct 2009

Primary outcomePrimary: Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) — -0.2; 0.3 units on scale — p=0.0445

Summary

The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)	-0.2; 0.3	0.0445 sig

Eligibility Criteria

Inclusion Criteria

Subject is 21 years of age or older
Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
Negative pregnancy test if female of childbearing potential
Subject is in general good health
Subject required treatment of joint pain within the last 90 days
Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion Criteria

Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
Subject is pregnant or breast-feeding
Subject is receiving systemic chemotherapy
Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
Subject has history of major depressive disorder not controlled with medication
Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis

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Data sourced from ClinicalTrials.gov (NCT00420992). 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.