PainPhase 3NCT00832416

A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee

A Phase 3 study testing Tramadol Once A Day in people with Pain and Osteoarthritis, Knee, run by Labopharm Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo 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 Once A Day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 565 participants
Where: No sites listed yet
Study dates: Jan 2003to Aug 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

Males or Females between the ages of 40-75 with a diagnosis of moderate to severe osteoarthritis of the knee, consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis 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.
C-reactive protein (CRP) < 8 ug/ml (if available at local lab) or erythrocyte sedimentation rate (ESR) < 40 mm/hr
Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of > 150 mm at Baseline corresponding with moderate to severe Osteoarthritis.
Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
Research Ethics Board (REB) approval of the written Informed Consent Form in Spanish or English which was signed and dated by the patient and Investigator, 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; or collagen gene mutations.
Evidence of effusion greater than 15 cubic centimetre (cc) upon physical examination of the joint at Baseline (Visit 1).
Body Mass Index (BMI) ≥ 38.
Major illness, requiring hospitalization during the 3 months before commencement of the screening period.
The patient was unwilling to stop taking pain medication (for arthritis or other types of pain) or was unwilling to stop taking other medications for the treatment of osteoarthritis (OA).

Show all 18Show fewer

Previous failure or discontinuation (due to adverse events) of tramadol hydrochloride (HCl) therapy.
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; or any other drug that reduces seizure threshold.
Treatment with another investigational agent within the last 30 days.
A history of seizure disorder other than Infantile Febrile Seizures.
Previous or current opioid dependency.
Bowel disease causing malabsorption.
Pregnancy or lactating or childbearing potential and unwilling to utilize a medically approved method of contraception during participation in this clinical trial.
Significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range.
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 have adversely affected the patient's ability to complete the study or its measures.

About this study

The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo

Conditions: Pain, Osteoarthritis, Knee
Being tested: Tramadol Once A Day, Placebo
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 Once A DayDrug
One Tramadol Once A Day tablet at randomized dose daily.
PlaceboDrug
One Placebo tablet daily.

Study groups in NCT00832416
Study group	Role	What they receive
1 Tramadol Once A Day 100mg	Experimental	Not described Receives: Drug: Tramadol Once A Day
2: Tramadol Once A Day 200mg	Experimental	Not described Receives: Drug: Tramadol Once A Day
3: Tramadol Once A Day 300mg	Experimental	Not described Receives: Drug: Tramadol Once A Day
4: Placebo	Experimental	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Global Rating of Pain for the Study Period (12 Weeks)
3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer.
Measured: 12 weeks
Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)
Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Measured: Baseline to week 12
Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)
Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.
Measured: Baseline to week 12

Secondary outcomes (5)

Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Measured: Week 0, week 3, week 6
Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm).
Measured: Week 0, week 3, week 6
Multiple Dose Effect Using 24-hour VAS Pain Questionnaire
Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).
Measured: 12 weeks
Investigator Global Rating of Pain Relief
The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: "How do you rate this patient's overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective".
Measured: 12 weeks
Percentage of Participants Who Dropped Out From Trial by Dropout Reason
Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Aug 2003

First posted30 Jan 2009 (estimated)
Study startJan 2003
Primary completionAug 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 565 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00832416
Sponsor's protocol ID: MDT3-002
Other IDs: NCT00832416
Status last verified: Apr 2012
First submitted: 29 Jan 2009
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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 Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT00832416
Acronym / sponsor ID: MDT3-002
Conditions: Pain, Osteoarthritis, Knee
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 565 participants (actual)
Lead sponsor: Labopharm Inc.Industry (pharma, biotech, devices)
Study start: Jan 2003
Primary completion: Aug 2003 (actual)
First posted: 30 Jan 2009 (estimated)
Results: Posted 3 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 and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1 Tramadol Once A Day 100mg	Experimental	Drug: Tramadol Once A Day
2: Tramadol Once A Day 200mg	Experimental	Drug: Tramadol Once A Day
3: Tramadol Once A Day 300mg	Experimental	Drug: Tramadol Once A Day
4: Placebo	Experimental	Drug: Placebo

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males or Females between the ages of 40-75 with a diagnosis of moderate to severe osteoarthritis of the knee, consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee:
C-reactive protein (CRP) < 8 ug/ml (if available at local lab) or erythrocyte sedimentation rate (ESR) < 40 mm/hr
Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of > 150 mm at Baseline corresponding with moderate to severe Osteoarthritis.
Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
Research Ethics Board (REB) approval of the written Informed Consent Form in Spanish or English which was signed and dated by the patient and Investigator, prior to study participation.

Key exclusion criteria (18 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; or collagen gene mutations.
Evidence of effusion greater than 15 cubic centimetre (cc) upon physical examination of the joint at Baseline (Visit 1).
Body Mass Index (BMI) ≥ 38.
Major illness, requiring hospitalization during the 3 months before commencement of the screening period.

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 DayOne Tramadol Once A Day tablet at randomized dose daily.	Drug	1 Tramadol Once A Day 100mg, 2: Tramadol Once A Day 200mg, 3: Tramadol Once A Day 300mg
PlaceboOne Placebo tablet daily.	Drug	4: Placebo

Primary outcome

Patient Global Rating of Pain for the Study Period (12 Weeks)
Time frame: 12 weeks
3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer.
Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)
Time frame: Baseline to week 12
Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)
Time frame: Baseline to week 12
Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.

5 secondary outcomes

Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Time frame: Week 0, week 3, week 6
Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Time frame: Week 0, week 3, week 6
Multiple Dose Effect Using 24-hour VAS Pain Questionnaire
Time frame: 12 weeks
Investigator Global Rating of Pain Relief
Time frame: 12 weeks
Percentage of Participants Who Dropped Out From Trial by Dropout Reason
Time frame: 12 weeks

Results and safety

Results posted to the registry on 3 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1: Tramadol Once A Day 100mg	110	64
2: Tramadol Once A Day 200mg	113	60
3: Tramadol Once A Day 300mg	115	54
4: Placebo	227	144

Primary outcome: Patient Global Rating of Pain for the Study Period (12 Weeks)

Time frame: 12 weeks. Number. Unit: participants

Measure	1: Tramadol Once A Day 100mg n = 108	2: Tramadol Once A Day 200mg n = 109	3: Tramadol Once A Day 300mg n = 113	4: Placebo n = 223
Very effective	19	16	26	29
Effective	50	56	56	94
Ineffective	39	37	31	100

Population analysed: The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.

Primary outcome: Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)

Time frame: Baseline to week 12. Mean (Standard Deviation). Unit: Percentage difference

Measure	1: Tramadol Once A Day 100mg n = 109	2: Tramadol Once A Day 200mg n = 110	3: Tramadol Once A Day 300mg n = 113	4: Placebo n = 226
Value	36.3 (45.3)	36.6 (40.9)	41.0 (44.5)	38.0 (41.7)

Primary outcome: Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)

Time frame: Baseline to week 12. Mean (Standard Deviation). Unit: Percentage difference

Measure	1: Tramadol Once A Day 100mg n = 109	2: Tramadol Once A Day 200mg n = 110	3: Tramadol Once A Day 300mg n = 113	4: Placebo n = 226
Value	31.9 (46.0)	37.0 (39.3)	37.3 (41.7)	33.7 (44.3)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1: Tramadol Once A Day 100mg	2 of 110 (1.8%)	31 of 110 (28.2%)	Not reported
2: Tramadol Once A Day 200mg	1 of 113 (0.9%)	49 of 113 (43.4%)	Not reported
3: Tramadol Once A Day 300mg	4 of 115 (3.5%)	57 of 115 (49.6%)	Not reported
4: Placebo	3 of 227 (1.3%)	38 of 227 (16.7%)	Not reported

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.
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, 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 18 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 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?

Patient Global Rating of Pain for the Study Period (12 Weeks) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT00832416.

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.