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OpenTrials
Completed

NCT Number: NCT01510912

Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Premier Research Group - Phoenix, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

35 mg bid or tid Capsules

Primary outcomes

  1. Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination

    Time frame: 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.

Other outcomes

  1. Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET

    Time frame: Baseline to Week 52/Early Termination

    The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.

  2. Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET

    Time frame: Baseline to Week 52/Early Termination

    The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.

Sponsors and collaborators

Lead sponsor

Iroko Pharmaceuticals, LLC

Industry

Registry information

Official study title

A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2012
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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