Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Helping Olfaction and Nutrition On Renal Replacement

ID
Name
2015P001231
Description
This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.
Trial arms
Trial start
2015-10-01
Estimated PCD
2022-07-01
Trial end
2022-07-01
Status
Completed
Phase
Early phase I
Treatment
Theophylline
The study medication will be provided by Foundation Care.
Arms:
Nasal theophylline
Size
7
Primary endpoint
Change From Baseline in Smell Identification Test Score at 6 Weeks
Baseline and every 2 weeks for 6 weeks
Change From Baseline in Smell Threshold Test Score at 6 Weeks
Baseline and every 2 weeks for 6 weeks
Eligibility criteria
Inclusion Criteria: * ESRD requiring chronic outpatient hemodialysis * Able to provide written consent * Defects in smell identification and/or smell threshold detection as measured by "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and Smell Threshold Test Exclusion Criteria: * Prior allergic reaction to theophylline * Patients currently treated with theophylline for clinical indication * Pregnancy or lactation * ESRD patients on peritoneal dialysis * Patients hospitalized at the time of study enrollment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}
Updated at
2024-01-09

1 organization

1 product

2 indications

Organization
Massachusetts General Hospital
Product
Theophylline
Indication
End-Stage Renal Disease
Indication
Loss of Smell