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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:
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01579890
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Mallinckrodt:

Intervention Details:
    Drug: Diclofenac
    diclofenac topical lotion
  Eligibility

Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01579890     History of Changes
Other Study ID Numbers: 105-95
Study First Received: April 16, 2012
Last Updated: April 17, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013