Endoscopic Evaluation of Diclofenac-K 25mg Soft Capsule

• Research type

  Research Study

• Full title

  Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with diclofenac-K 25 mg soft capsule: a comparison with diclofenac-K 2x12.5 mg tablets, acetylsalicylic acid 2x 500 mg tablets and ibuprofen 2x200 mg liquid capsules three times per day for 5 days

• IRAS ID

  22542

• Sponsor organisation

  Novartis Consumer Health S.A.

• Eudract number

  2009-011278-14

• ISRCTN Number

  1

• Research summary

  The purpose of the current study is to compare the gastro-duodenal tolerability of diclofenac-K 25 mg soft capsule with diclofenac-K 12.5 mg tablet over a 5 day period at a daily dose of 75 mg, the maximum treatment duration and maximum daily dose for non-prescription use of oral low dose diclofenac-K formulations within the EU. To place the results from the diclofenac formulations into context, two established and commonly used non-prescription analgesics will be included as comparator treatments (aspirin and ibuprofen).A screening visit will be conducted to determine if the volunteer is eligible. This will be conducted from up to -28 days before the first dose of any study drugs.If eligible the volunteer will enter the study and will receive 3 doses of the study drug per day for 5 days. The study will be conducted as an 'out-patient' study, where there will be no overnight stays in the research unit.Endoscopic assessments will be made at screening, baseline and at the end of the treatment period to assess any changes in the stomach and duodenum. Small biopsies will also be taken at screening and end-of-study endoscopies to measure levels of prostaglandin, an inflammatory substance produced in the stomach.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/26

• Date of REC Opinion

  14 May 2009

• REC opinion

  Favourable Opinion