NCT01331746 is a Phase 2 clinical trial of APD515 in Xerostomia in Advanced Cancer Patients, sponsored by Acacia Pharma Ltd.

Who is sponsoring NCT01331746?

NCT01331746 is sponsored by Acacia Pharma Ltd.

What drugs are being tested in NCT01331746?

Interventions in NCT01331746: APD515, Placebo.

What condition does NCT01331746 study?

NCT01331746 studies Xerostomia in Advanced Cancer Patients.

Is NCT01331746 still recruiting?

NCT01331746 is currently completed. Last updated 15 May 2013.

Last reviewed 2013-05-15 · How we verify

NCT01331746

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 15 May 2013

What this trial tests

Phase 2 trial testing APD515 in Xerostomia in Advanced Cancer Patients in 32 participants. Completed in 1 December 2012.

Timeline

1 September 2011

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Acacia Pharma Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	1 September 2011
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	11 locations across Denmark, United Kingdom

Drugs / interventions tested

APD515 — full drug profile →
Placebo

Conditions studied

Xerostomia in Advanced Cancer Patients — all drugs for Xerostomia in Advanced Cancer Patients →

Sponsor

Acacia Pharma Ltd — full company profile →

Who can join

18 and older, any sex, with Xerostomia in Advanced Cancer Patients. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Xerostomia score
Time frame: 1 week
Change in score on 100 mm visual analogue scale

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Acacia Pharma Ltd trials

Trials by the same sponsor.

NCT05546359 — Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients · Phase 2, PHASE3 · completed
NCT04849650 — PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment · Phase 1 · completed
NCT03583489 — Study of APD421 With and Without Ondansetron · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01331746 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Acacia Pharma Ltd
Last refreshed: 15 May 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01331746.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing