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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014