Clinical Trials Directory

Trials / Completed

CompletedNCT01331746

Proof-of-concept (PoC) Study of APD515

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Acacia Pharma Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A study to look at the effectiveness of a drug called APD515, designed to be applied to the lining inside the mouth, at relieving dryness of the mouth. Study will compare one week of treatment with APD515 to one week of treatment with matching placebo to see which has better effect on patient's mouth dryness, according to their own score.

Conditions

Interventions

TypeNameDescription
DRUGAPD51520 mg oromucosal-oral administration qds for 7 days
DRUGPlaceboqds for 7 days

Timeline

Start date
2011-09-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2011-04-08
Last updated
2013-05-16

Locations

11 sites across 2 countries: Denmark, United Kingdom

Source: ClinicalTrials.gov record NCT01331746. Inclusion in this directory is not an endorsement.