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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD515 | Experimental | Active APD515 treatment 20 mg qds for 7 days |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD515 | Drug | 20 mg oromucosal-oral administration qds for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Xerostomia score | Change in score on 100 mm visual analogue scale | 1 week |
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Inclusion Criteria:
Aged ≥ 18 years
Able and willing to give written informed consent.
Confirmed primary neoplasm at any site (apart from non-melanoma skin cancers), for which first-line cytotoxic therapy has been completed more than one month prior to study entry. Ongoing palliative, hormonal, cytostatic or "targeted" (e.g., monoclonal antibody, tyrosine kinase inhibitor, etc) therapy is permitted, provided that the risk of oral mucositis in the subject is not judged to be significant.
Subjective complaint of dry mouth, ongoing for at least two weeks prior to study entry.
Capacity for salivary stimulation, as demonstrated by stimulated whole saliva flow rate > unstimulated whole saliva flow rate.
Karnofsky performance score ≥ 60% or ECOG performance status ≤ 2.
Adequate renal and hepatic function and hydration status:
Adequate haematological function:
For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Davies, MD | Royal Surrey County Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Århus University Hospital | Aarhus | Denmark | ||||
| University of Copenhagen |
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| Placebo |
| Drug |
qds for 7 days |
|
| Copenhagen |
| Denmark |
| Hillerød Hospital | Hillerød | Denmark |
| Sue Ryder Leckhampton Court Hospice | Cheltenham | United Kingdom |
| Coventry and Warwickshire Partnership Trust | Coventry | United Kingdom |
| Royal Surrey County Hospital | Guildford | United Kingdom |
| John Eastwood Hospice | Mansfield | United Kingdom |
| Priscilla Bacon Lodge | Norwich | United Kingdom |
| City Hospital Hayward House Specialist Palliative Care Unit | Nottingham | United Kingdom |
| Scarborough General Hospital | Scarborough | United Kingdom |
| Severn Hospice | Shrewsbury | United Kingdom |