Knee osteoarthritis MedDRA version: 14.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Voltadol Forte Schmerzgel
Product Name: Diclofenac diethylamine 2.32 Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac diethylamine
CAS Number: 78213-16-8
Other descriptive name
Sponsors
Novartis Consumer Health S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must give written informed consent before any assessment is performed. At screening visit 2. Male or female = 50 years old; 3. Symptomatic OA of one or both knees, according to American College of Rheumatology (ACR) criteria, diagnosed at least 6 months previously; 4. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 5. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if = 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 6. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1 2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study; 7. If female of childbearing potential (not postmenopausal for>1 year or surgically sterilized), agree to maintain an effective method of contraception throughout the study. At baseline visit 8. Negative pregnancy test if female of child-bearing potential; 9. POM in one knee (which is designated as the target knee) higher by = 25 mm vs. the other knee; 10. POM in the target knee increased by = 10 mm vs. screening visit; 11. POM = 50 mm in the target knee; 12. Pain was predominant in the target knee during the entire screening period and for 6 months preceding the screening visit; 13. Radiograph of the target knee, no more than one year old, showing evidence of OA, Kellgren-Lawrence grade 1-3; 14. No current hip or back pain 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 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: General 1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 2.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. Long QT syndrome or QTc>450 ms for males and >470 ms for females at screening or baseline 4.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases 5.Pregnant or nursing women 6.If a female of childbearing potential (i.e. not>1 year postmenopausal or surgically sterilized), agree to maintain an effective method of contraception throughout the study. Particular exclusion criteria 7.Partial or total replacement of either knee joint, past or planned/expected during study 8.OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (common risk factors, such as obesity and past meniscectomy or ligament rupture and repair are allowed) 9.History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis) or laboratory values indicative of such disease with subsequent diagnosis by a physician 10.Fibromyalgia within the previous year 11.Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs, or any of the ingredients in the gel (isopropyl alcohol, propylene glycol or butylhydroxytoluene) or any other contraindication for study drug or rescue medication 12.Skin lesions or wounds in the affected area 13.Evidence of active peptic ulceration within the previous year or history of gastrointestinal bleeds 14.Clinically significant medical disease, which would compromise the subject’s welfare or confound the study results, such as severe/uncontrolled renal, hepatic, hematological, endocrine, cardiovascular, and neurological diseases within the previous year 15.Use of any of the following treatments prior to the screening visit or between screening and baseline visit: i)any topical analgesic or anti-inflammatory treatment on either knee within the previous month, ii)any intra-articular or peri-articular procedures or injections in either knee within the previous 3 months, iii)any systemic treatment with corticosteroids within the previous 6 weeks (topical treatments with corticosteroids not related to either knee are permitted), iv)any chondroprotectant or disease-modifying OA drugs, such as glucosamine or chondroitin sulfate, unless dose was stable over the previous month and will be maintained throughout the study, v)opiates, muscle relaxants or tranquilizers within the previous month except stable low doses of antidepressants, anxiolytics, and sleeping aids taken at bedtime, present at the screening visit and maintained throughout the study, vi) any systemic anti-inflammatory or analgesic drugs at screening if 5 times their elimination half-time exceeds 7 days (i.e., if half-life >33.6 h), vii) anticoagulants such as warfarin or heparin in the preceding week or antiaggregants within the previous month other than aspirin at stable low doses started at least one month before randomization and kept at a constant dose throughout the study, viii) any other investigational drugs within the previous month; 16. Any of the following prior to the baseline visit: i)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of DDEA 2.32% gel b.i.d. vs. vehicle on POM after 2 weeks of treatment in patients suffering from knee OA.;Secondary Objective: To study the onset and the durability of the effect of the study medication in the target knee and its effect in the contralateral knee over 4 weeks; To determine persistence of the effect of the study medication over 12 hours when applied twice daily; To determine the effect of the study medication on Night Pain and Morning Stiffness when applied in the evening; To determine the treatment effect using a standardized model of Induced Pain (10 min Walk Test); To evaluate the safety of the regimen by physical examination, ECG, and clinical laboratory before and after treatment, and by monitoring vital signs, local tolerability, and AEs throughout the treatment. ;Primary end point(s): Outcome of POM, assessed on a 100-mm visual analogue scale;Timepoint(s) of evaluation of this end point: After 2 weeks treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • POM at visits other than Visit 4; • POM in the contralateral knee at all post-baseline visits; • WOMAC Pain, Function and Stiffness subscales at all post-baseline visits; • Induced Pain (Walk Test) at all post-baseline visits; • SF-12 (Short Form-12 Health Survey). ;Timepoint(s) of evaluation of this end point: • POM at visits other than Visit 4; • POM in the contralateral knee at all post-baseline visits; • WOMAC Pain, Function and Stiffness subscales at all post-baseline visits; • Induced Pain (Walk Test) at all post-baseline visits; • SF-12 (Short Form-12 Health Survey) at all visits. • | — |
Countries
Germany
Contacts
Public ContactSponsor
Novartis Consumer Health SA
Outcome results
None listed