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Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579890
First Posted: April 18, 2012
Last Update Posted: April 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
Mallinckrodt
  Purpose
This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.

Condition Intervention
Osteoarthritis of the Hand Drug: Diclofenac

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Intervention Details:
    Drug: Diclofenac
    diclofenac topical lotion
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • diagnosed osteo or rheumatoid arthritis
  • Oral NSAIDs were not deemed appropriate treatment
  • Completed diclofenac sensitivity patch test with negative result
  • Signed informed consent form

Exclusion Criteria:

  • At the discretion of the physician and HPB
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01579890     History of Changes
Other Study ID Numbers: 105-95
First Submitted: April 16, 2012
First Posted: April 18, 2012
Last Update Posted: April 19, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action