Chronic PainPhase 3NCT00348010
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee
A Phase 3 study testing Tramadol HCl ER in people with Chronic Pain, run by Bausch Health Americas, Inc..
Trial summary
The purpose of this study is to compare the analgesic effectiveness and safety of tramadol HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The study hypothesis is that tramadol HCl ER is effective and safe in the treatment of OA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Tramadol HCl ER
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Jul 2001
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee; involvement of at least one knee joint that warrants treatment with NSAIDs, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit; patients with radiographic evidence of osteoarthritis within the last 6 months; patients with a pain intensity in index joint > = 40 mm on the visual analog scale (VAS) at the baseline visit; patients who are able to discontinue NSAIDs, COX-2 selective inhibitors, and other analgesics during the washout period and throughout double-blind study.
Who cannot join
- Patients with a medical condition, other than OA, uncontrolled with treatment or any clinically significant condition that, in the investigator's opinion, precludes study participation or interferes with the assessment of chronic pain and other OA symptoms; patients with a diagnosis of inflammatory arthritis, gout, pseudo-gout or Paget's disease, that, in the investigator's opinion, interferes with the assessment of pain and other symptoms of OA; patients with a diagnosis of chronic pain syndrome, patients with an ACR or a clinical diagnosis of fibromyalgia; patients with a clinically significant form of joint disease or prior joint replacement surgery at the index joint; patients with an anticipated need for surgery or other invasive procedure in the index joint.
About this study
Official title: Double-blind, Randomized, Dose-titration, Parallel-group Comparison of the Efficacy and Safety of Extended Release Tramadol Hydrochloride (Tramadol HCl ER) and Placebo in the Treatment of Osteoarthritis of the Knee.
The purpose of this study is to compare the analgesic effectiveness and safety of tramadol HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The study hypothesis is that tramadol HCl ER is effective and safe in the treatment of OA.
Read the detailed description
Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short elimination half-life of IR tramadol requires every 4-6 hour dosing to maintain optimal levels of analgesia in chronic pain. The study medication in this study is a once-daily, extended-release (ER) tramadol formulation. This is a 12-week, multi-center, double-blind, randomized, dose-titration, parallel-group, placebo-controlled study designed to evaluate the analgesic effectiveness and safety of once daily tramadol HCl ER with placebo in the treatment of patients with OA of the knee. Patients with OA Functional Class I-III of the knee will be eligible for participation, if appropriate criteria are met. After a 2-7 day washout period, during which the use of all analgesic medications used for chronic pain management will be discontinued, patients experiencing moderate to severe pain (pain intensity >= 40 mm on a 100 mm visual analog scale) in the index knee and who meet all other study criteria will enter a 2-week, double-blind, titration period. During this period, patients will be randomly assigned to treatment with tramadol HCl ER or placebo, once daily (QD). The initial dose will be tramadol HCl ER 100 mg or matching placebo QD. On Day 4 and for the remainder of the week, patients will be titrated to 200 mg or matching placebo QD, based on tolerability. Beginning at Visit 3, a minimum dose of 200 mg or matching placebo QD are to be maintained for the remainder of the 12-week study. Patients unable to tolerate at least 200 mg or matching placebo QD will be discontinued from the study. After Week 1 (Visit 3), further increases to 300 mg or 400 mg or matching placebo QD were permitted, depending on the adequacy of pain relief and tolerability of side effects. Efficacy and safety evaluations will be collected at study visits occurring at Weeks 1, 2, 4, 8, and 12 or at early termination. Study medication will be discontinued at Week 12 and patients will return after 1 week for a post-treatment visit (Week 13).
- Conditions
- Chronic Pain
- Being tested
- Tramadol HCl ER
- Keywords
- osteoarthritis, knee pain, extended release analgesia, opioid
- Medical subject headings
- Chronic Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HCl ERDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome is the change in arthritis pain intensity score
averages over the 12 weeks of the study.
Secondary outcomes (4)
The secondary outcomes include change from baseline in the daily arthritis
pain intensity VAS score from patient diaries; WOMAC OA Index pain subscale
scores for pain and physical function, patient's global assessment, patient's
sleep assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startNov 2000
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 245 participants
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348010
- Sponsor's protocol ID
- B00.CT3.015.TRA PO3
- Status last verified
- Jun 2012
- First submitted
- 2 Jul 2006
- Last updated
- 21 Jun 2012
- Results posted
- No
Publications
Babul N, Noveck R, Chipman H, Roth SH, Gana T, Albert K. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage. 2004 Jul;28(1):59-71. doi: 10.1016/j.jpainsymman.2003.11.006.
PubMed 15223085
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Dose-titration, Parallel-group Comparison of the Efficacy and Safety of Extended Release Tramadol Hydrochloride (Tramadol HCl ER) and Placebo in the Treatment of Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00348010
- Acronym / sponsor ID
- B00.CT3.015.TRA PO3
- Conditions
- Chronic Pain
- Keywords
- osteoarthritis, knee pain, extended release analgesia, opioid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2000
- Study completion
- Jul 2001
- First posted
- 4 Jul 2006 (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 compare the analgesic effectiveness and safety of tramadol HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The study hypothesis is that tramadol HCl ER is effective and safe in the treatment of OA.
Detailed description
Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short elimination half-life of IR tramadol requires every 4-6 hour dosing to maintain optimal levels of analgesia in chronic pain. The study medication in this study is a once-daily, extended-release (ER) tramadol formulation. This is a 12-week, multi-center, double-blind, randomized, dose-titration, parallel-group, placebo-controlled study designed to evaluate the analgesic effectiveness and safety of once daily tramadol HCl ER with placebo in the treatment of patients with OA of the knee. Patients with OA Functional Class I-III of the knee will be eligible for participation, if appropriate criteria are met. After a 2-7 day washout period, during which the use of all analgesic medications used for chronic pain management will be discontinued, patients experiencing moderate to severe pain (pain intensity >= 40 mm on a 100 mm visual analog scale) in the index knee and who meet all other study criteria will enter a 2-week, double-blind, titration period. During this period, patients will be randomly assigned to treatment with tramadol HCl ER or placebo, once daily (QD). The initial dose will be tramadol HCl ER 100 mg or matching placebo QD. On Day 4 and for the remainder of the week, patients will be titrated to 200 mg or matching placebo QD, based on tolerability. Beginning at Visit 3, a minimum dose of 200 mg or matching placebo QD are to be maintained for the remainder of the 12-week study. Patients unable to tolerate at least 200 mg or matching placebo QD will be discontinued from the study. After Week 1 (Visit 3), further increases to 300 mg or 400 mg or matching placebo QD were permitted, depending on the adequacy of pain relief and tolerability of side effects. Efficacy and safety evaluations will be collected at study visits occurring at Weeks 1, 2, 4, 8, and 12 or at early termination. Study medication will be discontinued at Week 12 and patients will return after 1 week for a post-treatment visit (Week 13).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee; involvement of at least one knee joint that warrants treatment with NSAIDs, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit; patients with radiographic evidence of osteoarthritis within the last 6 months; patients with a pain intensity in index joint > = 40 mm on the visual analog scale (VAS) at the baseline visit; patients who are able to discontinue NSAIDs, COX-2 selective inhibitors, and other analgesics during the washout period and throughout double-blind study.
Key exclusion criteria (1 listed)
- Patients with a medical condition, other than OA, uncontrolled with treatment or any clinically significant condition that, in the investigator's opinion, precludes study participation or interferes with the assessment of chronic pain and other OA symptoms; patients with a diagnosis of inflammatory arthritis, gout, pseudo-gout or Paget's disease, that, in the investigator's opinion, interferes with the assessment of pain and other symptoms of OA; patients with a diagnosis of chronic pain syndrome, patients with an ACR or a clinical diagnosis of fibromyalgia; patients with a clinically significant form of joint disease or prior joint replacement surgery at the index joint; patients with an anticipated need for surgery or other invasive procedure in the index joint.
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 HCl ER | Drug | – |
Primary outcome
The primary efficacy outcome is the change in arthritis pain intensity score
averages over the 12 weeks of the study.
4 secondary outcomes
The secondary outcomes include change from baseline in the daily arthritis
pain intensity VAS score from patient diaries; WOMAC OA Index pain subscale
scores for pain and physical function, patient's global assessment, patient's
sleep assessment
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 21 Jun 2012.
- Background: PubMed 15223085Babul N, Noveck R, Chipman H, Roth SH, Gana T, Albert K. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage. 2004 Jul;28(1):59-71. doi: 10.1016/j.jpainsymman.2003.11.006.
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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 HCl ER in people with Chronic Pain, run by Bausch Health Americas, 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 1 inclusion and 1 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 21 Jun 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?
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?
The primary efficacy outcome is the change in arthritis pain intensity score. The study lists 2 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 NCT00348010, 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 21 Jun 2012.