Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Diclofenac

• Registration Number: NCT01510912
• Lead Sponsor: Iroko Pharmaceuticals, LLC

Brief Summary

The purpose of this study is to evaluate the safety of Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-04
• Results First Submitted: 2014-04-08
• Results First Submitted QC: 2014-04-08
• Last Update Submitted: 2014-04-08
• Results First Posted: 2014-05-09
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

• Male or female ≥ [greater than or equal to] 40 years of age
• If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety
• Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
• Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening

Exclusion Criteria

• Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
• Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
• Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
• Has significant difficulties swallowing capsules or is unable to tolerate oral medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diclofenac Capsules 35 mg bid or tid	Diclofenac	-

Primary Outcome Measures

Name	Time	Method
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination	Baseline to Week 52/Early Termination	The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.

Trial Locations

Locations (36)

Premier Research Group - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Lynn Institute of the Ozarks; 🇺🇸 Little Rock, Arkansas, United States

Acri-Phase I, LLC; 🇺🇸 Anaheim, California, United States

Med Center; 🇺🇸 Carmichael, California, United States

Expresscare Clinical Research; 🇺🇸 Colorado Springs, Colorado, United States

Westside Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Well Pharma Medical Research, Corporation; 🇺🇸 Miami, Florida, United States

Peninsula Research, Inc; 🇺🇸 Ormond Beach, Florida, United States

Alliance Clinical Research; 🇺🇸 Winter Park, Florida, United States

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