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NCT04195100
Local Pilocarpine for Relieving Dry Mouth
EARLY_PHASE1 trial testing Pilocarpine Ophthalmic Solution in Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth in 14 participants. Completed in 31 January 2020.
1 December 2019
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 14 |
| Start date | 1 April 2019 |
| Primary completion | 1 December 2019 |
| Estimated completion | 31 January 2020 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Pilocarpine Ophthalmic Solution — full drug profile →
Conditions studied
- Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth — all drugs for Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth →
Sponsor
Maastricht University Medical Center
Who can join
70 and older, any sex, with Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators intended for this study to deliver the "proof-of-concept" that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.
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:
- PubMed search for NCT04195100
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04195100 (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 Maastricht University Medical Center
- Last refreshed: 28 February 2020
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/NCT04195100.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing