Relieve pain and swelling in joints, muscles
Conditions
Interventions
Trade Name: Topical Diclofenac
Product Name: Topical Diclofenac Spray
Product Code: TDS - 943
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: Diclofenac Sodium
CAS Number: 15307-79-6
Curren
Sponsors
Wyeth Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is cleared by a site-affiliated physician. - Females are not pregnant or breast feeding. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range ;Inclusion criteria: - Subject is cleared by a site-affiliated physician. - Females are not pregnant or breast feeding. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - history of any hypersensitivity (including asthma, rhinitis, or urticaria) to diclofenac or to any of the excipients used in the topical spray, or to aspirin or any other NSAID, or to paracetamol; - on chronic nonsteroidal anti-inflammatory drug therapy, defined as taking a daily regimen 5 to 7 days/week; - history (within the past 2 years) of a cutaneous reaction to any pharmaceutical or non-pharmaceutical product; ;Exclusion criteria: - history of any hypersensitivity (including asthma, rhinitis, or urticaria) to diclofenac or to any of the excipients used in the topical spray, or to aspirin or any other NSAID, or to paracetamol; - on chronic nonsteroidal anti-inflammatory drug therapy, defined as taking a daily regimen 5 to 7 days/week; - history (within the past 2 years) of a cutaneous reaction to any pharmaceutical or non-pharmaceutical product;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety - to assess application site reactions;Secondary Objective: ;Primary end point(s): Percentage of subjects discontinuing from the study.;Main Objective: Safety - to assess application site reactions;Secondary Objective: ;Primary end point(s): Percentage of subjects discontinuing from the study. | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed