Pharmaceutical products

Tender description

TIPAL IPM There is a plan to conduct a clinical trial of an investigational medical product according to Good Clinical Practice and Medicines and Healthcare Products Regulatory Agency regulations. This trial will involve 298 patients from between 25 and 35 sites within the UK. Patients will receive oral lansoprazole 30 mg (as 2 x 15 mg tablets) twice daily or matched placebo for 12 months. The manufacturer will provide a sIMPD and an Annex 13 compliant label for regulatory purposes. There is a plan to conduct a clinical trial of an investigational medical product according to good clinical practice and medicines and healthcare products regulatory agency regulations. This trial will involve 298 patients from between 25 and 35 sites within the UK. Patients will receive oral lansoprazole 30 mg (as 2 x 15 mg tablets) twice daily or matched placebo for 12 months. The manufacturer will provide a sIMPD and an Annex 13 compliant label for regulatory purposes.