OsteoarthritisPhase 2NCT00752661
An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
A Phase 2 study testing Tramadol Hydrochloride; JNS013 in people with Osteoarthritis and Low Back Pain, run by Janssen Pharmaceutical K.K..
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Osteoarthritis, Low Back Pain
- What is being tested?
- Tramadol Hydrochloride; JNS013
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: An Exploratory Study of an Active Ingredient of JNS013-tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
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).
Read the 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.
- Conditions
- Osteoarthritis, Low Back Pain
- Being tested
- Tramadol Hydrochloride; JNS013
- Keywords
- osteoarthritis, low back pain, oral drug, tramadol
- Medical subject headings
- Osteoarthritis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Hydrochloride; JNS013Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intensity of pain from the beginning of dose-finding period (baseline) to the final assessment point, by using VAS.
Secondary outcomes (1)
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startJun 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752661
- Sponsor's protocol ID
- CR013900
- Status last verified
- Aug 2010
- First submitted
- 11 Sep 2008
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of an Active Ingredient of JNS013-tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
- ClinicalTrials.gov ID
- NCT00752661
- Acronym / sponsor ID
- CR013900
- Conditions
- Osteoarthritis, Low Back Pain
- Keywords
- osteoarthritis, low back pain, oral drug, tramadol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol Hydrochloride; JNS013 | Drug | – |
Primary outcome
Change in the intensity of pain from the beginning of dose-finding period (baseline) to the final assessment point, by using VAS.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- An exploratory study of an active ingredient of JNS013 - tramadol hydrochloride in patients with osteoarthritis of the knee or low back painLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol Hydrochloride; JNS013 in people with Osteoarthritis and Low Back Pain, run by Janssen Pharmaceutical K.K..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the intensity of pain from the beginning of dose-finding period (baseline) to the final assessment point, by using VAS.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.