A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain; Pain Intensity Assessment; Osteoarthritis; Arthralgia; Sciatica
Intervention: CG 5503;tapentadol (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50
mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in
patients who have chronic pain.
Official title: A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
Secondary outcome: The secondary outcomes, among others, include COWS and SOWS assessments; patient assessment of constipation symptoms; vomiting and sleep assessments; pain intensity assessment; patient global impression of change.
CG5503 is a centrally active pain-relieving drug being investigated for the treatment of
acute and chronic pain. This study is designed to assess the safety of CG5503 Immediate
Release (IR) in men and women who are 18 years of age or older and who have had chronic (for
at least 3 months) low-back pain or chronic pain from osteoarthritis of the hip or knee, and
who require daily analgesic medication. In this double blind study (neither patients nor
investigators will know what treatment is given), patients will be randomly (patients are
assigned different treatments based on chance) assigned to receive either CG5503 base IR or
oxycodone IR to begin a 90 day treatment during which each patient will return to the medical
facility every 2 weeks. For the CG5503 IR group, patients will take 50 or 100 mg orally every
4 to 6 hours as needed to a maximum dose of 600 mg per day. Oxycodone IR patients will take
10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day. Patients
may continue taking their regular, stable, non-opioid medication throughout the study. The
effectiveness of study treatment (CG5503 base IR or oxycodone) will be assessed with
11-Point Numerical Rating Scale and Patient Global Impression of Change. Using these scales,
patients will indicate their pain intensity level and overall status of their well-being.
Opioid withdrawal symptoms of CG5503 IR dose of 50 or 100 mg will be assessed with clinical
opioid withdrawal scale [Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate
Withdrawal Scale (COWS)] at the end of treatment. Using these scales, patients will indicate
the physical components of drug withdrawal and the severity of symptoms associated with rapid
withdrawal. Safety will be assessed using physical examination, monitoring of adverse events,
clinical and laboratory measures, and 12 lead electrocardiogram (ECG) results. Constipation,
vomiting, and sleep assessments will be performed. No formal hypothesis testing will be done
in this study.
For the CG5503 IR group, patients will take a flexible dose of 50 or 100 mg orally every 4 to
6 hours as needed to a maximum dose of 600 mg per day for 90 days. Oxycodone IR patients will
take a flexible dose of 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of
90 mg per day for 90 days.
Minimum age: 18 Years.
Maximum age: N/A.
- A clinical diagnosis of one of the following: low-back pain of non-malignant origin
for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
- Require daily doses of analgesia medication for chronic pain that is consistent with
or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief
- Post-washout baseline pain intensity score >4 on an 11-point numerical rating scale
- History of seizure disorder or epilepsy
- Uncontrolled hypertension
- Currently treated with monoamine oxidase inhibitors
- Systemic steroid therapy, excluding inhalers or topical steroids, within 3 months
- History of malignancy within the past 2 years, with the exception of basal cell
Locations and Contacts
Starting date: July 2006
Ending date: July 2007
Last updated: October 11, 2007