To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).

• Sponsor: Glenmark Pharmaceuticals Ltd. India (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02596451
• Collaborator: (none)
• Enrollment: 1,164
• Locations: 44
• Arms: 3
• Duration (Months): 7
• Patients Per Site: 26.5
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Diclofenac Sodium gel, 1%; Drug: Voltaren® Gel; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diclofenac Sodium gel, 1% apply gel to the target knee	Drug: Diclofenac Sodium gel, 1%
Active Comparator: Voltaren® Gel apply gel to the target knee	Drug: Voltaren® Gel
Placebo Comparator: Placebo apply gel to the target knee	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee [Baseline and week 4]

   The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.

2. OA Symptoms for at least 6 months prior to screening.

3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.

Exclusion Criteria:

1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.

2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.

3. History of gastrointestinal bleeding or peptic ulcer disease.

4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).

5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.

6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glenmark Investigational Site 5	Mesa	Arizona	United States
2	Glenmark Investigational Site 1	Anaheim	California	United States
3	Glenmark Investigational Site 21	Anaheim	California	United States
4	Glenmark Investigational Site 31	Anaheim	California	United States
5	Glenmark Investigational Site 26	Canoga Park	California	United States
6	Glenmark Investigational Site 42	Carlsbad	California	United States
7	Glenmark Investigational Site 30	Carmichael	California	United States
8	Glenmark Investigational Site 33	Cerritos	California	United States
9	Glenmark Investigational Site 25	El Cajon	California	United States
10	Glenmark Investigational Site 24	La Mesa	California	United States
11	Glenmark Investigational Site 2	Pasadena	California	United States
12	Glenmark Investigational Site 13	Rancho Cucamonga	California	United States
13	Glenmark Investigational Site 27	Sacramento	California	United States
14	Glenmark Investigational Site 10	Fort Lauderdale	Florida	United States
15	Glenmark Investigational Site 41	Hialeah	Florida	United States
16	Glenmark Investigational Site 3	Miami Lakes	Florida	United States
17	Glenmark Investigational Site 15	Miami	Florida	United States
18	Glenmark Investigational Site 19	Miami	Florida	United States
19	Glenmark Investigational Site 28	Miami	Florida	United States
20	Glenmark Investigational Site 32	Miami	Florida	United States
21	Glenmark Investigational Site 40	Miami	Florida	United States
22	Glenmark Investigational Site 37	Ormond Beach	Florida	United States
23	Glenmark Investigational Site 11	West Palm Beach	Florida	United States
24	Glenmark Investigational Site 18	West Palm Beach	Florida	United States
25	Glenmark Investigational Site 8	Evanston	Illinois	United States
26	Glenmark Investigational Site 43	Newburgh	Indiana	United States
27	Glenmark Investigational Site 38	Wichita	Kansas	United States
28	Glenmark Investigational Site 17	New Orleans	Louisiana	United States
29	Glenmark Investigational Site 22	Saginaw	Michigan	United States
30	Glenmark Investigational Site 14	Saint Louis	Missouri	United States
31	Glenmark Investigational Site 9	Englewood	Ohio	United States
32	Glenmark Investigational Site7	Altoona	Pennsylvania	United States
33	Glenmark Investigational Site 36	Knoxville	Tennessee	United States
34	Glenmark Investigational Site 39	Nashville	Tennessee	United States
35	Glenmark Investigational Site 23	Beaumont	Texas	United States
36	Glenmark Investigational Site 20	Bryan	Texas	United States
37	Glenmark Investigational Site 34	Dallas	Texas	United States
38	Glenmark Investigational Site 35	Houston	Texas	United States
39	Glenmark Investigational Site 44	Houston	Texas	United States
40	Glenmark Investigational Site 4	Lampasas	Texas	United States
41	Glenmark Investigational Site 29	San Antonio	Texas	United States
42	Glenmark Investigational Site 6	San Antonio	Texas	United States
43	Glenmark Investigational Site 16	Charlottesville	Virginia	United States
44	Glenmark Investigational Site12	Midlothian	Virginia	United States

Sponsors and Collaborators

• Glenmark Pharmaceuticals Ltd. India

Investigators

• Study Director: Mahesh V Deshpande, Glenmark Pharmaceuticals Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glenmark Pharmaceuticals Ltd. India
• ClinicalTrials.gov Identifier: NCT02596451
• Other Study ID Numbers: GLK-1402
• First Posted: Nov 4, 2015
• Last Update Posted: Jun 28, 2017
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Osteoarthritis; Diclofenac

Study Results

Participant Flow

Arm/Group Title	Test	Reference	Placebo
Arm/Group Description	Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)	Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)	Vehicle gel (Glenmark Pharmaceuticals Ltd)
Period Title: Overall Study
STARTED	385	392	387
COMPLETED	381	374	373
NOT COMPLETED	4	18	14

Baseline Characteristics

Arm/Group Title	Test	Reference	Placebo	Total
Arm/Group Description	Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)	Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)	Vehicle gel (Glenmark Pharmaceuticals Ltd)	Total of all reporting groups
Overall Participants	383	382	378	1143
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.2 (10.36)	56.5 (10.68)	56.7 (10.52)	56.4 (10.51)
Sex: Female, Male (Count of Participants)
Female	249 65%	237 62%	248 65.6%	734 64.2%
Male	134 35%	145 38%	130 34.4%	409 35.8%

Outcome Measures

1. Primary Outcome

Title	Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
Description	The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
Time Frame	Baseline and week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test	Reference
Arm/Group Description	Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)	Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
Measure Participants	309	285
Mean (Standard Deviation) [units on a scale]	5.8 (3.96)	5.9 (3.94)

Adverse Events

Arm/Group Title	Test		Reference		Placebo
Arm/Group Description	Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)		Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)		Vehicle gel (Glenmark Pharmaceuticals Ltd)
All Cause Mortality
	Test		Reference		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test		Reference		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/383 (0%)		2/382 (0.5%)		1/378 (0.3%)
Gastrointestinal disorders
Nausea	0/383 (0%)	0	1/382 (0.3%)	1	0/378 (0%)	0
Injury, poisoning and procedural complications
Rib Fracture	0/383 (0%)	0	1/382 (0.3%)	1	0/378 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	0/383 (0%)	0	1/382 (0.3%)	1	0/378 (0%)	0
Asthma	0/383 (0%)	0	0/382 (0%)	0	0/378 (0%)	0
Surgical and medical procedures
L Ankle Surgery Secondary To Trimalleolar Fracture	0/383 (0%)	0	1/382 (0.3%)	1	0/378 (0%)	0
Right Ankle Surgery Due To Stair Fall	0/383 (0%)	0	0/382 (0%)	0	1/378 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Test		Reference		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/383 (7.3%)		26/382 (6.8%)		23/378 (6.1%)
Nervous system disorders
Headache	28/383 (7.3%)	38	26/382 (6.8%)	46	23/378 (6.1%)	36

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.