A Safety Study of TDS-943
- Conditions
- Of Product: Relieve pain and swelling in joints, muscles
- Registration Number
- EUCTR2004-001586-18-GB
- Lead Sponsor
- Wyeth Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>to compare the amount of gastroduodenal ulcers/erosions between compounds;Primary end point(s): Percentage of subjects discontinuing from the study.
- Secondary Outcome Measures
Name Time Method