PainPhase 3NCT00833794
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
A Phase 3 study testing Tramadol Once a day in people with Pain and Osteoarthritis, run by Labopharm Inc..
Trial summary
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Tramadol Once a day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,028 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jan 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females
- Must be between the ages of 40-80
- Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:
- Current knee pain
- Less than 30 minutes of morning stiffness with or without crepitus on active motion
- Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study
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- Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.
- Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).
- Must meet the following criteria for severity of pain at Visit 2 (Day S0):
- Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)
- Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale (range: 0-10) compared to the rating at Visit 1 (Day SX)
- Must have a erythrocyte sedimentation rate (ESR) < 40 mm/hr
- Must have oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials
- Must have signed and dated an approved written Informed Consent form in French, Spanish, English or Romanian, which has also been signed and dated by the Investigator (unless otherwise required by the ethics committee), prior to study participation
- Patients must continue to meet the open-label eligibility criteria and
- Must have a score of ≥ 4 on the Numerical Rating Scale (NRS) with a total increase of ≥ 2 points on the NRS compared to Visit 3(Day R14) and
- Must not have taken any of the prohibited medications during the Open-label Phase.
Who cannot join
- Has known rheumatoid arthritis or any other rheumatic disease
- Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations
- Has a history of bursitis of the knee (target knee)
- Has a history of pain in the ipsilateral hip (target knee)
- Has had a meniscal tear in the target knee within the last 12 months
- Has had cartilage reconstruction procedure in the target knee
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- Has had a therapeutic arthroscopy procedure in the target knee within the last 12 months
- Has a Body Mass Index (BMI) greater than 37
- Has had a major illness, requiring hospitalisation during the 3 months before commencement of the screening period
- Is unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or is unwilling to stop taking other medications for the treatment of OA
- Has previously failed treatment with tramadol or discontinued treatment with tramadol due to adverse events
- Has been taking other opioids (e.g. codeine, oxycodone, hydromorphone, etc.) for treatment of OA or other chronic conditions
- Has received Corticosteroid Injections in the target knee within the last 3 months or Viscous injections in the target knee within the last 6 months
- Has had treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors or any other drug that reduces seizure threshold
- Has had treatment with another investigational agent within the last 30 days
- Has a history of seizure disorder other than Infantile Febrile Seizures
- Has a previous or current opioid dependency
- Has a bowel disease causing malabsorption
- Is pregnant, lactating or of childbearing potential and is unwilling to utilise a medically approved method of contraception during participation in this clinical trial
- Has significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range
- Has significant renal disease (defined as creatinine clearance <30 mL/min
- Has a history of current or past substance abuse or dependence, other than nicotine
- Has a known and documented allergy to tramadol or any structurally similar drugs (e.g. opiates)
- Has a known and documented allergy to acetaminophen or any structurally similar drugs
- Has any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures.
- Patient Request
- Adverse Events that contraindicate further administration of the study medication
- Any other situation where in the opinion of the Investigator continued participation in the study would not be in the patient's best interest.
About this study
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
- Conditions
- Pain, Osteoarthritis
- Being tested
- Tramadol Once a day, Placebo
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Once a dayDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 Tramadol Once A Day | Experimental | Not described Receives: Drug: Tramadol Once a day |
| 2 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.
Measured: 12 weeks
Secondary outcomes (9)
Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain
Measured: 6 weeks
Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)
Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.
Measured: 12 weeks
WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.
Measured: 12 weeks
WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.
Measured: 12 weeks
Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
Measured: 12 weeks
Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
Measured: week 12
Time to Response
Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.
Measured: 12 weeks
Discontinuation Due to Lack of Efficacy
The number of patients who discontinued due to lack of efficacy was reported.
Measured: 12 weeks
Discontinuation Due to Adverse Events
The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startOct 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833794
- Sponsor's protocol ID
- MDT3-005
- Other IDs
- NCT00833794
- Status last verified
- Apr 2012
- First submitted
- 29 Jan 2009
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Burch F, Fishman R, Messina N, Corser B, Radulescu F, Sarbu A, Craciun-Nicodin MM, Chiriac R, Beaulieu A, Rodrigues J, Beignot-Devalmont P, Duplan A, Robertson S, Fortier L, Bouchard S. A comparison of the analgesic efficacy of Tramadol Contramid OAD versus placebo in patients with pain due to osteoarthritis. J Pain Symptom Manage. 2007 Sep;34(3):328-38. doi: 10.1016/j.jpainsymman.2006.11.017. Epub 2007 Jun 21.
PubMed 17583466
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
- ClinicalTrials.gov ID
- NCT00833794
- Acronym / sponsor ID
- MDT3-005
- Conditions
- Pain, Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 10 Aug 2009
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 compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Tramadol Once A Day | Experimental | Drug: Tramadol Once a day |
| 2 Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males or females
- Must be between the ages of 40-80
- Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:
- Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.
- Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).
Key exclusion criteria (28 listed)
- Has known rheumatoid arthritis or any other rheumatic disease
- Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations
- Has a history of bursitis of the knee (target knee)
- Has a history of pain in the ipsilateral hip (target knee)
- Has had a meniscal tear in the target knee within the last 12 months
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 Once a day | Drug | 1 Tramadol Once A Day |
| Placebo | Drug | 2 Placebo |
Primary outcome
Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
Time frame: 12 weeks
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.
9 secondary outcomes
Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment
Time frame: 6 weeks
Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)
Time frame: 12 weeks
WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Time frame: 12 weeks
WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Time frame: 12 weeks
Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Time frame: 12 weeks
Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Time frame: week 12
Time to Response
Time frame: 12 weeks
Discontinuation Due to Lack of Efficacy
Time frame: 12 weeks
Discontinuation Due to Adverse Events
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17583466Burch F, Fishman R, Messina N, Corser B, Radulescu F, Sarbu A, Craciun-Nicodin MM, Chiriac R, Beaulieu A, Rodrigues J, Beignot-Devalmont P, Duplan A, Robertson S, Fortier L, Bouchard S. A comparison of the analgesic efficacy of Tramadol Contramid OAD versus placebo in patients with pain due to osteoarthritis. J Pain Symptom Manage. 2007 Sep;34(3):328-38. doi: 10.1016/j.jpainsymman.2006.11.017. Epub 2007 Jun 21.
- Approved labellingLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol Once a day in people with Pain and Osteoarthritis, run by Labopharm Inc..
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 17 inclusion and 28 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 30 Apr 2012. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833794, which also lists 1 linked publication.
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 30 Apr 2012.