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Proof-of-concept (PoC) Study of APD515

NCT01331746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-05-16

No results posted yet for this study

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

  • Xerostomia in Advanced Cancer Patients

Interventions

DRUG

APD515

20 mg oromucosal-oral administration qds for 7 days

DRUG

Placebo

qds for 7 days

Sponsors & Collaborators

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Andrew Davies, MD · Royal Surrey County Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Denmark
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331746 on ClinicalTrials.gov