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This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.
Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria
Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Sodium Gel | Experimental | Diclofenac Sodium Gel, 1% |
|
| Voltaren® Gel | Active Comparator | Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% |
|
| Placebo gel | Placebo Comparator | Placebo gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac sodium gel 1% | Drug | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the Total WOMAC Pain Subscale Score | Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)]. The timepoints considered for the primary outcomes include baseline and week 4. | From baseline to week 4 |
| Change From Baseline in WOMAC Pain Subscale Score | Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo. Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)]. The timepoints considered for the primary outcomes include baseline and week 4. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yashoda Hospital - Malakpet | Hyderabad | Andhra Pradesh | 500036 | India | ||
| Yashoda Hospital -Secunderabad |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Sodium Gel | Diclofenac Sodium Gel, 1% Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| FG001 | Voltaren® Gel | Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2016 | Jan 13, 2021 |
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| Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% | Drug | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
|
| Placebo gel | Drug | Vehicle Gel 4 gm, 4 times a day for 4 weeks |
|
| Secunderabad |
| Andhra Pradesh |
| 500003 |
| India |
| Yashoda Hospital -Somajiguda | Somajiguda | Andhra Pradesh | 500082 | India |
| King George Hospital | Visakhapatnam | Andhra Pradesh | 530002 | India |
| Riddhi Medical Nursing Home | Ahmedabad | Gujarat | 380008 | India |
| Rathi Hospital | Ahmedabad | Gujarat | 380015 | India |
| Sanjivani Superspeciality Hospital Pvt. Ltd | Ahmedabad | Gujarat | 380015 | India |
| B.J Medical College & Civil Hospital | Ahmedabad | Gujarat | 380016 | India |
| GMERS Medical College & Civil Hospital | Ahmedabad | Gujarat | 380061 | India |
| Medistar Multispeciality Hospital | Himmatnagar | Gujarat | 383001 | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat | 360005 | India |
| SSG Hospital and Medical College | Vadodara | Gujarat | 39000 | India |
| Anand Multispeciality Hospital | Vadodara | Gujarat | 390016 | India |
| Parul Sevashram Hospital | Vadodara | Gujarat | 391760 | India |
| Omega Hospital | Mangalore | Karnataka | 575002 | India |
| Mysore Medical College and Research Institute | Mysore | Karnataka | 570001 | India |
| Sree Narayana Institute of Medical Science | Ernākulam | Kerala | 683594 | India |
| Sir J. J. Group of Hospital and Grant Government Hospital | Mumbai | Maharashtra | 400008 | India |
| Lokmanya Tilak Municipal Medical College & General Hospital | Mumbai | Maharashtra | 400022 | India |
| Government Medical College and Hospital | Nagpur | Maharashtra | 440003 | India |
| Jasleen Hospital | Nagpur | Maharashtra | 440012 | India |
| Institute of Medical sciences and Lata Mangeshkar | Nagpur | Maharashtra | 600001 | India |
| Supe Heart and Diabetes Hospital & Research Centre | Nashik | Maharashtra | 422002 | India |
| BJ medical college & Sassoon General Hospital | Pune | Maharashtra | 411001 | India |
| Sancheti Institute for Orthopedics & Rehabilitation | Pune | Maharashtra | 411005 | India |
| BhaktiVedanta Hospital and Research Institute | Thane | Maharashtra | 401107 | India |
| IMS and SUM Hospital | Bhubaneswar | Odisha | 751003 | India |
| Govt Stanley Medical College & Hospital | Chennai | Tamil Nadu | 600001 | India |
| M.V. Hospital & Research Centre | Lucknow | Uttar Pradesh | 226003 | India |
| Ajanta Research Centre | Lucknow | Uttar Pradesh | 226005 | India |
| OM surgical Centre and Maternity Home | Varanasi | Uttar Pradesh | 221007 | India |
| Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics | Kolkata | West Bengal | 700020 | India |
| FG002 | Placebo Gel | Placebo gel Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Sodium Gel | Diclofenac Sodium Gel, 1% Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| BG001 | Voltaren® Gel | Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| BG002 | Placebo Gel | Placebo gel Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| WOMAC Pain subscale score for target knee | Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = minimum 0 to maximum 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)]. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in the Total WOMAC Pain Subscale Score | Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)]. The timepoints considered for the primary outcomes include baseline and week 4. | The PP Population was used for analysis of clinical equivalence between Mylan's Diclofenac gel and Voltaren gel. The primary outcome tested in this population was the equivalence of Mylan's Diclofenac sodium gel (1%) verses the Voltaren gel (1%) and thus only Diclofenac Sodium Gel and Voltaren Gel arms are present here. The placebo arm is presented for the superiority analysis. | Posted | Mean | Standard Deviation | score on a scale | From baseline to week 4 |
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|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in WOMAC Pain Subscale Score | Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo. Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)]. The timepoints considered for the primary outcomes include baseline and week 4. | The mITT Population was used for analysis of superiority of Mylan's Diclofenac gel and Voltaren gel over placebo. The primary outcome tested in this population was the superiority of Mylan's Diclofenac sodium gel (1%) and the Voltaren gel (1%) over placebo and thus all the three arms are presented here. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
The reporting period for TEAEs started after the informed consent through day 28 after the last application of investigational product, a total of approximately 12 weeks.
The safety analysis was performed based on safety population that includes all patients who were treated with at least one application of the investigational product. The total number of patients included in this population were 1203 (398 for Mylan's Diclofenac gel, 405 for Voltaren gel and 400 for placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diclofenac Sodium Gel | Diclofenac Sodium Gel, 1% Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks | 0 | 398 | 0 | 398 | 11 | 398 |
| EG001 | Voltaren® Gel | Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks | 1 | 405 | 1 | 405 | 19 | 405 |
| EG002 | Placebo Gel | Placebo gel Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks | 0 | 400 | 0 | 400 | 20 | 400 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Completed Suicide | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prasanna C Ganapathi, Associate Vice President, Global Clinical Sciences | Mylan Pharmaceuticals Pvt Ltd. | 08066728952 | 28952 | PrasannaC.Ganapathi@mylan.in |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2018 | Jan 13, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
|
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
| OG002 | Placebo Gel | Placebo gel Placebo gel: Vehicle Gel 4 gm, 4 times a day for 4 weeks |
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