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

Osteoarthritis of the Hand Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01579890
• Other study ID #: 105-95
• Status: Approved for marketing
• Phase: N/A
• First received: April 16, 2012
• Last updated: April 17, 2012

Study information

• Verified date: April 2012
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Expanded Access

Clinical Trial Summary

This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Osteoarthritis of the Hand

Intervention

Drug:
• Diclofenac
diclofenac topical lotion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mallinckrodt	Nuvo Research Inc.