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

Primary Purpose

Osteoarthritis of the Hand

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Diclofenac
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Osteoarthritis of the Hand

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 16, 2012
    Last Updated
    April 17, 2012
    Sponsor
    Mallinckrodt
    Collaborators
    Nuvo Research Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01579890
    Brief Title
    Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mallinckrodt
    Collaborators
    Nuvo Research Inc.

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of the Hand

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac
    Intervention Description
    diclofenac topical lotion

    10. Eligibility

    Sex
    All
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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