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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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15 July 2013 |
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Main ID: |
EUCTR2004-001586-18-GB |
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Date of registration:
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23/02/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety Study of TDS-943
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Scientific title:
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A Safety Study of TDS-943 |
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Date of first enrolment:
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26/10/2004 |
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Target sample size:
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75 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001586-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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:
- 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Of Product: Relieve pain and swelling in joints, muscles
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Intervention(s)
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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
Current Sponsor code: TDS-943
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 4-
Trade Name: Celecoxib
Product Name: Celecoxib
Product Code: NDC-0025-1525-31
Pharmaceutical Form: Capsule*
INN or Proposed INN: Celecoxib
Other descriptive name: Celecoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Naproxen
Product Name: Naproxen
Product Code: NDC 18393-277-42
Pharmaceutical Form: Capsule*
INN or Proposed INN: Naproxen Sodium
Other descriptive name: Naproxen Sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
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Primary Outcome(s)
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Main Objective: Safety - to assess Gastric Mucosal Prostaglandin Synthesis between comparitors
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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
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Primary end point(s): Percentage of subjects discontinuing from the study.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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