Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis
Primary Purpose
Osteoarthitis, Chronic Pain, Knee Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
tapentadol HCl
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthitis focused on measuring Tapentadol, Osteoarthritis, Analgesia, Chronic pain
Eligibility Criteria
Inclusion Criteria:
- Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months
- Moderate to severe chronic pain due to knee osteoarithritis
Exclusion Criteria:
- Previously opioid treated subject who had a history of withdrawal after cessation of the opioid
- History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate
- Subjects with history of uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg)
- Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit
Sites / Locations
Outcomes
Primary Outcome Measures
Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.
Secondary Outcome Measures
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the last timepoint or 29 days
Full Information
NCT ID
NCT00745069
First Posted
August 29, 2008
Last Updated
May 17, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Grünenthal GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00745069
Brief Title
Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis
Official Title
4-Week Randomized Multicenter DB, Placebo- and Active-controlled, Parallel-group, Forced-titration Phase 2B Study of Efficacy and Safety With CG5503 Prolonged Release (PR) to 233 mg BID and Oxycodone PR to 20 mg BID vs Placebo in Subjects With Moderate to Severe Chronic Pain of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Grünenthal GmbH
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to examine a low and high dose of tapentadol extended release tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum concentrations and safety of tapentadol and oxycodone were also examined.
Detailed Description
Arthritis is the most common chronic debilitating disease in the United States (more than 43 million people or 1 in 6). Osteoarthritis of the knee is a very common and a major cause of disability. Pharmacological treatment includes the following analgesics: non-steroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase II (COX-II) inhibitors, acetaminophen and opioids. Despite the numerous available analgesic medications, 60% to 80% of patients suffering from chronic pain are currently treated inadequately. Opioid analgesics have been shown to be efficacious in chronic non-malignant pain and can be an important therapeutic asset. The study was a 4-week randomized multicenter double-blind, placebo- and active-controlled, parallel-group, forced-titration phase 2B study of efficacy and safety with tapentadol extended release (ER) to 233 mg BID and oxycodone PR to 20 mg BID vs placebo in subjects with moderate to severe chronic pain of knee osteoarthritis. Primary efficacy outcome was the average pain intensity 24 hours before the last evaluation time or 29 days. Safety was evaluated by reporting of adverse events, laboratory tests, vital sign measures, ECGs. This study hypothesis was that tapentadol extended release was effective in relieving chronic moderate to severe pain from knee osteoarthritis compared to treatment with placebo using 2 dosing regimens for tapentadol.
tapentadol extended release white, fim-coated tablet taken orally twice a day during a 4-week period at a dose that steadily increased up to 100 mg or 200 mg; placebo tablets; or oxycodone extended release tablet, 20 mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthitis, Chronic Pain, Knee Pain
Keywords
Tapentadol, Osteoarthritis, Analgesia, Chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
670 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tapentadol HCl
Primary Outcome Measure Information:
Title
Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the last timepoint or 29 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months
Moderate to severe chronic pain due to knee osteoarithritis
Exclusion Criteria:
Previously opioid treated subject who had a history of withdrawal after cessation of the opioid
History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate
Subjects with history of uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg)
Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25985806
Citation
Eichenbaum G, Gohler K, Etropolski M, Steigerwald I, Pergolizzi J, Kim M, Vorsanger G. Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency. J Opioid Manag. 2015 May-Jun;11(3):211-27. doi: 10.5055/jom.2015.0270.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=561&filename=CR004183_CSR.pdf
Description
Efficacy and safety of tapentadol extended release tablets in the treatment of moderate to severe pain in subjects with knee osteoarthritis
Learn more about this trial
Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis
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