Overview

A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis

Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to compare the analgesic (a drug that relieves pain) effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo (no drug) in patients with osteoarthritis (OA).
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alza Corporation, DE, USA
Treatments:
Hydromorphone
Criteria
Inclusion Criteria:

- Patient must have a negative pregnancy test at screening and be postmenopausal for at
least 1 year or surgically sterile or practicing a medically recognized contraceptive
program

- Patient has been diagnosed with Functional Class I-III Osteoarthritis of the knee or
hip

- Patient has required treatment of target joint pain within the 90 days prior to study
start and met at least one of the following: was unable to consistently control target
joint pain with non-opioid pain reliever, unable to treat target joint pain with
non-opioid pain reliever because treatment was contraindicated per investigator
judgement, or had received an opioid(single or combination product) for treatment of
target joint pain, with the equivalent of less than or equal to 40 mg/day of oral
morphine sulfate, inclusive of breakthrough pain medication

- Patient has reported a target joint pain score of at least 5 (11-point Likert Scale)
at baseline

Exclusion Criteria:

- Patient for whom hydromorphone was contraindicated because of a documented history of
an allergic reaction (hives, rash, etc) or a clinically significant intolerance to
hydromorphone or other opioids

- Patient requiring treatment with monoamine oxidase inhibitors, or receiving systemic
chemotherapy or had an active malignancy of any type or had clinically significant
abnormalities in clinical chemistry, hematology or urinalysis, or had a documented
history of gout, pseudogout, Paget's disease, fibromyalgia

- uncontrolled inflammatory arthritis or NSAID-dependent inflammatory arthritis or any
chronic pain syndrome that could interfere with the assessment of pain and/or other
symptoms of osteoarthritis

- Patient who is pregnant and/or breastfeeding

- Patient with a documented history of drug abuse/dependence/misuse or narcotic
analgesic abuse/dependence/misuse, or unable to discontinue all formulations of prior
pain medications (opioid and/or non-opioid) during the washout period of the study

- Patient who had a documented history of a medical condition, which, in the
investigator's opinion, could compromise the patient's ability to swallow, absorb,
metabolize, or excrete study drug, including (but not limited to) intractable nausea
and/or vomiting, and/or severe gastrointestinal narrowing