TDS-943 MAXIMUM USE TOLERANCE STUDY
- Conditions
- Relieve pain and swelling in joints, muscles
- Registration Number
- EUCTR2004-000035-28-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.
- 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
;
- 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
- 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;
;
- 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;
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 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.
- Secondary Outcome Measures
Name Time Method