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Osteoarthritis, KneePhase 2NCT00904462

Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee

A Phase 2 study testing Lidoderm in people with Osteoarthritis, Knee, run by Endo USA Inc., a Keenova Therapeutics Company at 24 sites in United States.

Completed

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

Official record
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Trial summary

Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the treatment of pain from OA of the knee. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Lidoderm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
24 sitesUnited States
Study dates
Aug 2004to Sep 2005
Phase
Phase 2
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

  • Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (presence of osteophytes on x-ray and written evaluation) of OA
  • Had functional capacity class rating of I, II, or III according to ACR classification
  • Had normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
  • Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for non study pain
  • At baseline visit, patients were randomized to double-blind treatment if they had an average pain intensity rating for the index joint of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 is defined as "no pain" and 10 is defined as "pain as bad as ever imagined" as measured by Question 5 of the BPI and recorded in a diary
  • At baseline visit, patients were randomized to double-blind treatment if they had, at the baseline visit, an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee

Who cannot join

  • Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would have interfered with the assessment of pain and other symptoms of OA
  • Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that could have confounded study results
  • Had any other clinically significant joint disease or prior joint replacement surgery at the index joint
  • Had severe renal insufficiency (creatinine clearance of <30 mL/min)
  • Had moderate or greater hepatic impairment
  • Were taking analgesic medications, glucosamine, or chondroitin that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
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  • Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period.
  • Were using lidocaine-containing product that could not be discontinued during the study
  • Had previously failed treatment with Lidoderm analgesic patch for OA
  • Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry
  • Were unable to discontinue use of topical drugs applied to the knee
  • Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Study site

    Bartlett, Tennessee

  • Study site

    Berlin, New Jersey

  • Study site

    Bingham Farms, Michigan

  • Study site

    Birmingham, Alabama

  • Study site

    Boulder, Colorado

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cordova, Tennessee

  • Study site

    Dayton, Ohio

  • Study site

    DeLand, Florida

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Hueytown, Alabama

  • Study site

    Largo, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Palm Harbor, Florida

  • Study site

    Peabody, Massachusetts

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Reno, Nevada

  • Study site

    Springfield, Illinois

  • Study site

    St. Petersburg, Florida

  • Study site

    Tallassee, Alabama

  • Study site

    Wheaton, Maryland

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Pilot Study Comparing the Efficacy and Safety of Lidocaine 5% Patch With Placebo in Patients With Pain From Osteoarthritis of the Knee

Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the treatment of pain from OA of the knee.

Being tested
Lidoderm, Placebo patch
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidodermDrug

    Also called Lidocaine 5% patch

    Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

  • Placebo patchDrug

    Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

Study groups in NCT00904462
Study groupRoleWhat they receive
Lidocaine 5% patchExperimentalLidocaine 5% patch (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied on each affected knee once every 24 hours
Receives: Drug: Lidoderm
Placebo patchPlacebo comparatorMatching placebo patch, 1⅓ patches applied on each affected knee once every 24 hours
Receives: Drug: Placebo patch

What is being measured

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

  1. Western Ontario and McMaster Universities (WOMAC) OA Index

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  2. Pain intensity and pain relief (BPI Questions 3, 4, 5, 6, and 8)

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  3. Pain Quality Assessment Scale (PQAS)

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  4. Patient-rated and Investigator-rated Global Impression of Change in OA pain (categorical scale)

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  5. Patient-rated and Investigator-rated Global Assessment of Treatment Satisfaction (categorical scale)

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

Secondary outcomes (4)

  1. QoL: Pain interference on activities of daily living using Question 9 of the BPI

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  2. QoL: Beck Depression Inventory (BDI)

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  3. Quality of Sleep (QOS)

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

  4. Safety assessments included AEs, dermal assessments, clinical laboratory tests (including urinalysis), vital sign measurements, physical examination results, and plasma lidocaine concentrations

    Measured: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

Timeline

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

  1. First posted19 May 2009 (estimated)
  2. Study startAug 2004
  3. Primary completionSep 2005

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00904462
Sponsor's protocol ID
EN3260-001
Status last verified
Feb 2010
First submitted
15 May 2009
Last updated
10 Feb 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidoderm in people with Osteoarthritis, Knee, run by Endo USA Inc., a Keenova Therapeutics Company at 24 sites in United States.

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 6 inclusion and 12 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 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Western Ontario and McMaster Universities (WOMAC) OA Index (time frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)). The study lists 5 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 NCT00904462.

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 10 Feb 2010.

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