Phase II PoC study of APD515 v1.0

• Research type

  Research Study

• Full title

  Randomised, double-blind, placebo-controlled Phase II proof-of-concept study of APD515 solution for oromucosal and oral administration for relief of xerostomia in patients with cancer

• IRAS ID

  78821

• Sponsor organisation

  Acacia Pharma Ltd

• Eudract number

  2011-000978-53

• Clinicaltrials.gov Identifier

  NCT01331746

• Research summary

  A study of how effective APD515 is at treating dry mouth in advanced cancer patients, compared with placebo. APD515 is a special formulation of a well-known medicine, designed to be spread around the lining inside the mouth, kept in place for a couple of minutes and then swallowed. Subjects will take either APD515 or matching placebo (chosen randomly) 4 times a day for a week, then rest with no medicine for a week (wash-out period) and then take the opposite treatment for a week. Subjects' own assessment of their mouth dryness (scored on a scale from 0-100) will be recorded during the study to see which out of APD515 and placebo has the better effect.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  11/EE/0167

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Further Information Favourable Opinion