An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee

A Phase 3 study testing Tramadol Once A Day in people with 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 collect information regarding the long-term (6 and 12 months) safety of Tramadol HCl Once-A-Day(OAD) 300 mg. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Tramadol Once A Day
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 392 participants
Where: No sites listed yet
Study dates: Apr 2003to Jul 2004
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 American College of Rheumatology (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 two years prior to entry into the study.
Erythrocyte Sedimentation Rate (ESR) < 40 mm/hour.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale total score of >= 150 mm at baseline. (5 questions/100 mm scale each with an averaged response of 30 mm or higher per question).
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 Research Ethics Board (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 (Body Mass Index (BMI) >= 35) (National Institutes of Health (NIH), 2000).
Major illness requiring hospitalization during the 3 months before commencement of the screening period.
Patients who are unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or are unwilling to stop taking other medications for the treatment of osteoarthritis (OA).
Patients who have previously failed tramadol hydrochloride (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 collect information regarding the long-term (6 and 12 months) safety of Tramadol HCl Once-A-Day(OAD) 300 mg.

Conditions: Osteoarthritis, Knee
Being tested: Tramadol Once A Day
Keywords: Moderate to severe symptomatic osteoarthritis of the knee
Medical subject headings: 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

Study groups in NCT00833911
Study group	Role	What they receive
Tramadol Contramid® OAD	Experimental	Not described Receives: Drug: Tramadol Once A Day

What is being measured

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

Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation
Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population
Measured: 6 months and 12 months

Timeline

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

Apr 2003Jul 2004

First posted2 Feb 2009 (estimated)
Study startApr 2003
Primary completionJul 2004
Study completionJul 2004

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 Osteoarthritis, KneeStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 392 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00833911
Sponsor's protocol ID: MDT3-004
Other IDs: NCT00833911
Status last verified: Apr 2012
First submitted: 29 Jan 2009
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mongin G. Tramadol extended-release formulations in the management of pain due to osteoarthritis. Expert Rev Neurother. 2007 Dec;7(12):1775-84. doi: 10.1586/14737175.7.12.1775.
PubMed 18052769

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

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

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: An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT00833911
Acronym / sponsor ID: MDT3-004
Conditions: Osteoarthritis, Knee
Keywords: Moderate to severe symptomatic osteoarthritis of the knee
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 392 participants (actual)
Lead sponsor: Labopharm Inc.Industry (pharma, biotech, devices)
Study start: Apr 2003
Primary completion: Jul 2004 (actual)
Study completion: Jul 2004 (actual)
First posted: 2 Feb 2009 (estimated)
Results: Posted 2 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 collect information regarding the long-term (6 and 12 months) safety of Tramadol HCl Once-A-Day(OAD) 300 mg.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tramadol Contramid® OAD	Experimental	Drug: Tramadol Once A Day

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 American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1991):
Erythrocyte Sedimentation Rate (ESR) < 40 mm/hour.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale total score of >= 150 mm at baseline. (5 questions/100 mm scale each with an averaged response of 30 mm or higher per question).
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 Research Ethics Board (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 (Body Mass Index (BMI) >= 35) (National Institutes of Health (NIH), 2000).
Major illness requiring hospitalization during the 3 months before commencement of the screening period.
Patients who are unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or are unwilling to stop taking other medications for the treatment of osteoarthritis (OA).

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	Tramadol Contramid® OAD

Primary outcome

Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation
Time frame: 6 months and 12 months
Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population

Results and safety

Results posted to the registry on 2 Jun 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
300 mg Tramadol HCl OAD	392	371

Primary outcome: Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation

Time frame: 6 months and 12 months. Number. Unit: participants

Measure	All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum n = 392	6-months Safety n = 275	12-months Safety n = 168
Value	346	188	121

Population analysed: All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months. 6-months safety: patients who completed at least 175 days on treatment. 12-months safety: patients who completed at least 350 days on treatment.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum	9 of 392 (2.3%)	321 of 392 (81.9%)	Not reported
6-months Safety	1 of 275 (0.4%)	169 of 275 (61.5%)	Not reported
12-months Safety	0 of 168 (0%)	101 of 168 (60.1%)	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.
Results publication: PubMed 18052769Mongin G. Tramadol extended-release formulations in the management of pain due to osteoarthritis. Expert Rev Neurother. 2007 Dec;7(12):1775-84. doi: 10.1586/14737175.7.12.1775.
Approved labellingLink provided by the sponsor.

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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 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 2 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?

Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation (time frame: 6 months and 12 months). 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 NCT00833911, 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.