Of Product: Relieve pain and swelling in joints, muscles
Conditions
Interventions
Trade Name: Topical Diclofenac Spray
Product Name: Topical Diclofenac Spray
Product Code: TDS - 943
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: Diclofenac Sodium
CAS Number: 15307-79-6
Sponsors
Wyeth Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is cleared by a site-affiliated physician. - Unremarkable EGD at baseline. - healthy man or woman between 18 - 55 years of age. 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: - Active GI disease, Chronic or Acute renal or hepatic disorder; - history of any hypersensitivity (including asthma, rhinitis, or urticaria) to diclofenac or to any of the excipients used in the topical spray, or to celecoxib, naproxen or to aspirin or any other NSAID, or to paracetamol; - testing Positive for H.Pylori - any skin disorder/wound at the application site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety - to assess Gastric Mucosal Prostaglandin Synthesis between comparitors;Secondary Objective: To assess the effects on whole blood COX-1 and COX-2 activity and to compare the amount of gastroduodenal ulcers/erosions between compounds;Primary end point(s): Percentage of subjects discontinuing from the study. | — |
Countries
United Kingdom
Outcome results
None listed