PainPhase 3NCT00912015
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up
A Phase 3 study testing Tramadol OAD and Tramadol OAD 100mg in people with Pain and Osteoarthritis, Knee, run by Labopharm Inc..
Trial summary
The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pain, Osteoarthritis, Knee
- What is being tested?
- Tramadol OAD and Tramadol OAD 100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jul 2003
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female patients between the ages of 40-75 with a diagnosis of Osteoarthritis of the knee consistent with the ACR Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1991):
- 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 one year prior to entry into the study.
- ESR < 40 mm/hour
- WOMAC Pain Subscales total score of more than or equal to 150 mm at baseline.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- The Patient has signed and dated the REB approved, written, informed consent prior to study participation.
Who cannot join
- Known rheumatoid arthritis or any other rheumatoid disease.
- Secondary arthritis, i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations.
- Obesity Class II (BMI more than or equal to 35) (NIH, 2000)
- Major illness requiring hospitalization during the 3 months before commencement of the screening period.
- Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
- Patients who have previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to adverse events.
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- Patients who are taking or within the last 3 weeks have taken the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or other drugs which reduce seizure threshold.
- Patients who are taking or have taken another investigational agent within the last 30 days.
- Patients with a history of seizure disorder other than Infantile Febrile Seizures.
- Patients who are opioid dependent.
- Patients with bowel disease causing malabsorption.
- Patients who are pregnant or lactating or patients of child-bearing potential who are unwilling to utilize a medically approved method of contraception during participation in this clinical trial.
- Patients with significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range.
- Patients with significant renal disease, defined as creatinine clearance <30 mL/min as estimated by the method of Levey et al., 1999.
- Current substance abuse or dependence, other than nicotine.
- Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
- Any other condition that, in the opinion of the investigators, would adversely affect the patient's ability to complete the study or its measures.
About this study
The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg
- Conditions
- Pain, Osteoarthritis, Knee
- Being tested
- Tramadol OAD, Tramadol OAD 100mg
- Medical subject headings
- Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol OADDrug
Tramadol OADDrug
Tramadol OADDrug
Tramadol OAD 100mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol OAD 200mg | Experimental | Not described Receives: Drug: Tramadol OAD |
| Tramadol OAD 300mg | Experimental | Not described Receives: Drug: Tramadol OAD |
| Tramadol OAD 400mg | Experimental | Not described Receives: Drug: Tramadol OAD |
| Tramadol OAD 100mg | Other | Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions. Receives: Drug: Tramadol OAD 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events: 12-months Safety Population
Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMar 2002
- Primary completionJul 2003
- Study completionJul 2003
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 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
- NCT00912015
- Sponsor's protocol ID
- MDT3-001-E1-A1
- Other IDs
- NCT00912015
- Status last verified
- Apr 2012
- First submitted
- 9 Apr 2009
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up
- ClinicalTrials.gov ID
- NCT00912015
- Acronym / sponsor ID
- MDT3-001-E1-A1
- Conditions
- Pain, Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 3 Jun 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 evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tramadol OAD 200mg | Experimental | Drug: Tramadol OAD |
| Tramadol OAD 300mg | Experimental | Drug: Tramadol OAD |
| Tramadol OAD 400mg | Experimental | Drug: Tramadol OAD |
| Tramadol OAD 100mg | Other | Drug: Tramadol OAD 100mgDespite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female patients between the ages of 40-75 with a diagnosis of Osteoarthritis of the knee consistent with the ACR Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1991):
- ESR < 40 mm/hour
- WOMAC Pain Subscales total score of more than or equal to 150 mm at baseline.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- The Patient has signed and dated the REB approved, written, informed consent prior to study participation.
Key exclusion criteria (17 listed)
- Known rheumatoid arthritis or any other rheumatoid disease.
- Secondary arthritis, i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations.
- Obesity Class II (BMI more than or equal to 35) (NIH, 2000)
- Major illness requiring hospitalization during the 3 months before commencement of the screening period.
- Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
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 OAD | Drug | Tramadol OAD 200mg |
| Tramadol OAD | Drug | Tramadol OAD 300mg |
| Tramadol OAD | Drug | Tramadol OAD 400mg |
| Tramadol OAD 100mg | Drug | Tramadol OAD 100mg |
Primary outcome
Adverse Events: 12-months Safety Population
Time frame: 12 months
Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.
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.
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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 OAD and Tramadol OAD 100mg in people with Pain and Osteoarthritis, Knee, 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 8 inclusion and 17 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. 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 3 Jun 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?
Adverse Events: 12-months Safety Population (time frame: 12 months). 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 30 Apr 2012.