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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2006-003485-33-SE |
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Date of registration:
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17/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Duloxetine 60 to 120 mg versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain - HMFG
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Scientific title:
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Duloxetine 60 to 120 mg versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain - HMFG |
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Date of first enrolment:
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21/03/2007 |
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Target sample size:
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230 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003485-33 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Greece
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Are male or female outpatients at least 40 years of age.
- Meet the American College of Rheumatology (ACR) clinical and radiographic criteria for the diagnosis of osteoarthritis (OA) of the knee with pain for =14 days of each month for 3 months prior to study entry.
- Have a mean score of 4 or greater on the 24-hour average pain score (0-10).
- Are female of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding and test negative for pregnancy at Visit 1 or are postmenopausal. Females must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study.
- Have an educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator.
- Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
- Have agreed to maintain the same activity level throughout the course of the study.
- Have completed the daily diaries for at least 70% of the days between Visit 1 and Visit 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. “Immediate family” is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study).
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry (Visit 1).
- Have previously completed or withdrawn from this study or any other study investigating duloxetine.
- Have had previous exposure to duloxetine.
- Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
- Have major depressive disorder (MDD) as determined using depression module of the Mini International Neuropsychiatric Interview (MINI).
- Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- Are taking any excluded medications that cannot be discontinued at Visit 1.
- Have disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.
- Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
- Have a positive urine drug screen for any substance of abuse or excluded medication.
- Are pregnant or breast-feeding.
- Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- Have a history of recurrent seizures other than febrile seizures.
- Are judged clinically by the investigator to be at suicidal risk or as identified by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II) prior to starting study drug.
- Have uncontrolled narrow-angle glaucoma.
- Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
- Have known hypersensitivity to duloxetine or any of the inactive ingredients or patients with frequent or severe allergic reactions to multiple medications.
- Have frequent falls that could result in hospitalization or could compromise response to treatment.
- Have a confounding painful condition that may interfere with assessment of the index joint, that is, knee. (Knee pain should be the predominant pain. Mild OA of the hands is allowed, for instance.)
- Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto’s thyroiditis).
- Have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 3 months.
- Have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee at anytime.
- Have surgery planned during the trial for the index joint.
- Has had a prior synovial fluid analysis showing a white blood cell (WBC) =2000 mm3 that is indicative of a diagnosis other than OA.
- Are non-ambulatory or require the use of crutches or a walker.
- Have a body mass index (BMI) over 40.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Osteoarthritis Knee Pain
MedDRA version: 8.1
Level: LLT
Classification code 10023476
Term: Knee osteoarthritis
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Intervention(s)
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Trade Name: Cymbalta
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Cymbalta
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The primary efficacy measure for this study is the weekly mean of the 24-hour average pain scores calculated from patients’ daily diary asking for 24-hour average pain rating on an 11-point Likert scale. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).
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Main Objective: To assess the efficacy of duloxetine 60 to 120 mg once daily (QD) compared with placebo on the reduction of pain severity as measured by the weekly mean of the 24-hour average pain scores in patients with osteoarthritis (OA) knee pain during a 13-week, double-blind, treatment period using an 11-point Likert scale patient diary.
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Secondary Objective: Evaluate duloxetine 60 to 120 mg QD vs placebo on patients’ perceived improvement during the 13-week treatment phase
Evaluate duloxetine 60 to 120 mg QD vs placebo on the change in patients’ functioning during the 13-week treatment phase
Assess the efficacy of duloxetine 60 to 120 mg QD v placebo during the 13-week treatment phase
Assess the impact of treatment with duloxetine 60 to 120 mg QD vs placebo during the 13-week treatment phase on patient-reported health outcomes.
Evaluate whether reduction in pain is a direct analgesic effect of duloxetine and is independent of treatment effect on mood
Assess the safety of duloxetine vs placebo during the treatment phase on discontinuation rates, treatment-emergent adverse events (TEAEs), laboratory assessments, and vital signs
Compare the effect of treatment with duloxetine 60 mg for 12 weeks to the effect of treatment with duloxetine 60 mg for 6 weeks followed by treatment with duloxetine 120 mg for 6 weeks
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Secondary ID(s)
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F1J-MC-HMFG
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 21/03/2007
Contact:
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