An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
Primary Purpose
Osteoarthritis, Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tramadol Hydrochloride; JNS013
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, low back pain, oral drug, tramadol
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic pain due to OA of the knee or LBP that persists for more than 3 months at the initiation of the observation period
- Patients who received oral NSAIDs at a usual highest dose for at least 14 consecutive days during 3 months before the initiation of the observation period, but could not attain a sufficient analgesic effect
- Patients with the intensity of the strongest pain during 48 hours before the initiation of the observation period is >= 40 mm and < 80 mm on VAS
- Ambulatory outpatients
- Prior to the conduct of the study, patients who were given a sufficient explanation about the investigational product and this study and have given their own consent in writing to participate in the study.
Exclusion Criteria:
- Patients with conditions for which opioids are contraindicated
- Patients with a hypersensitivity to opioids
- Patients who received TRAM in the past and discontinued the treatment due to ineffectiveness or adverse reactions
- Patients with complications associated with pain to the degree considered to have an influence on the efficacy assessment (trauma such as fracture, headache, post-herpetic neuralgia)
- Patients with a complication of severe spinal disease
Sites / Locations
Outcomes
Primary Outcome Measures
Change in the intensity of pain from the beginning of dose-finding period (baseline) to the final assessment point, by using VAS.
Secondary Outcome Measures
Percentage of patients considered analgesic effect present based on the change in VAS, VAS on each assessment day, PI (pain intensity rating), PAR (pain relief rating), PID (pain intensity difference), PRID (pain relief combined with pain intensity).
Full Information
NCT ID
NCT00752661
First Posted
September 11, 2008
Last Updated
May 16, 2011
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT00752661
Brief Title
An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
Official Title
An Exploratory Study of an Active Ingredient of JNS013-tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to find the clinical dose range of an active ingredient of JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient analgesic effect from non-steroidal anti-inflammatory drugs (NSAIDs).
Detailed Description
Since JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with acetaminophen (APAP) inhibiting central COX-3, it is expected to have an intermediate effect between narcotic analgesics and NSAIDs (non-steroid anti-inflammatory drugs). This is a multicenter, open-label, dose response study. The purpose of this study is to find the clinical dose range of TRAM in patients with chronic pain due to osteoarthritis (OA) of the knee or low back pain (LBP) who cannot attain a sufficient analgesic effect from NSAIDs. The investigational product will be orally administered 4 times daily (after each meal and before bedtime) at a dose of 25 to 100 mg at least 4-hour intervals. Treatment will be started at an initial dose of 100 mg/day, and the dose is titrated by 25 mg every 7 days if the analgesic effect is insufficient and there is no problem with the safety. Treatment will be continued up to 35 days in total at a dose of 400 mg/day or a dose of which a sufficient analgesic effect can be obtained. The primary efficacy endpoint is the change in the intensity of pain from the beginning of dose-finding period (baseline) to the final assessment point (Up to Day 36), by using VAS (Visual Analog Scale). The safety evaluations are adverse events, laboratory examinations, blood pressure/pulse rate and body weight. Total study period of this study is 49days, Screening period is 7days, Administration period is 35 days and Follow-up period is 7 days. The investigational product will be orally administered 4 times daily (after each meal and before bedtime) at a dose of 25 to 100 mg at least 4-hour intervals. Treatment will be started at an initial dose of 100 mg/day, and the dose is titrated by 25 mg every 7 days if the analgesic effect is insufficient and there is no problem with the safety. Treatment will be continued up to 35 days in total at a dose of 400 mg/day or a dose of which a sufficient analgesic effect can be obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Low Back Pain
Keywords
osteoarthritis, low back pain, oral drug, tramadol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tramadol Hydrochloride; JNS013
Primary Outcome Measure Information:
Title
Change in the intensity of pain from the beginning of dose-finding period (baseline) to the final assessment point, by using VAS.
Secondary Outcome Measure Information:
Title
Percentage of patients considered analgesic effect present based on the change in VAS, VAS on each assessment day, PI (pain intensity rating), PAR (pain relief rating), PID (pain intensity difference), PRID (pain relief combined with pain intensity).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic pain due to OA of the knee or LBP that persists for more than 3 months at the initiation of the observation period
Patients who received oral NSAIDs at a usual highest dose for at least 14 consecutive days during 3 months before the initiation of the observation period, but could not attain a sufficient analgesic effect
Patients with the intensity of the strongest pain during 48 hours before the initiation of the observation period is >= 40 mm and < 80 mm on VAS
Ambulatory outpatients
Prior to the conduct of the study, patients who were given a sufficient explanation about the investigational product and this study and have given their own consent in writing to participate in the study.
Exclusion Criteria:
Patients with conditions for which opioids are contraindicated
Patients with a hypersensitivity to opioids
Patients who received TRAM in the past and discontinued the treatment due to ineffectiveness or adverse reactions
Patients with complications associated with pain to the degree considered to have an influence on the efficacy assessment (trauma such as fracture, headache, post-herpetic neuralgia)
Patients with a complication of severe spinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=414&filename=CR013900_CSR.pdf
Description
An exploratory study of an active ingredient of JNS013 - tramadol hydrochloride in patients with osteoarthritis of the knee or low back pain
Learn more about this trial
An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
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