Clinical trial reports and synopses
We post the results of our clinical trials on the LEO Pharma website, covering trials in patients as well as in healthy people. The results are posted in three formats:
• Clinical trial report, excluding appendices. See What is a clinical trial report.
• Clinical trial report synopsis (very short version of the report).
• Plain language summary. See What is a plain language summary.
Clinical trial reports and synopses are posted for phase 1-4 trials dating back to 1990*. Plain language summaries are posted for phase 2-4 trials completed after January 2018.
Synopses and plain language summaries are posted within 12 months after the trial is completed. Exception: Synopses for clinical trials in children (paediatric population) are posted within 6 months.
Clinical trial reports from trials investigating approved products in approved indications are posted after the results have been presented in an original research article in a peer-reviewed journal.
*Refers to the year of the clinical trial protocol.
Important information regarding LEO Pharma Clinical Trial Disclosure
Access to the site requires that you acknowledge and accept the following:
- The information on this website is provided solely to increase transparency of LEO Pharma clinical trials. It is not intended to promote any prescription, sale, or use, whether approved or off-label, of any medicinal product from LEO Pharma or from any other company.
- The documents on this site have been prepared in accordance with applicable ICH guidelines upon completion of the respective clinical trials. Except edits necessary for the protection of commercially confidential information and those for the protection of personal data, the documents are in the same format as they were originally prepared for approvals from the regulatory authorities.
- The documents provided on this site contain data and results regarding approved and non-approved uses, formulations or treatment regimens. As data and results from clinical trials are of a scientific nature, you cannot rely on this information as a recommendation or advice regarding the use/non-use of any products or treatment options.
- The information is not intended to replace the advice of a healthcare professional. As a patient, you must always consult your doctor for further information and instructions.
- The information is not intended to be used by physicians for making prescribing decisions. If you are a physician, you should always refer to the specific authority-approved labelling information approved for the product in the country or region of the patient.