| Trial ID: | L1177 |
| Source ID: | NCT02479451
|
| Associated Drug: |
Theophylline
|
| Title: |
Helping Olfaction and Nutrition On Renal Replacement
|
| Acronym: |
HONORR
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02479451/results
|
| Conditions: |
End Stage Renal Disease|Olfactory Disorders
|
| Interventions: |
DRUG: Theophylline
|
| Outcome Measures: |
Primary: Change From Baseline in Smell Identification Test Score at 6 Weeks, Smell identification test is a validated 40-item scratch and sniff smell identification test that was administered by study investigators. Scores on this test scale range between 0 (minimum) to 40 (maximum). Higher score indicates better ability for smell identification. Total scores are reported on this scale (no sub-scales). The unit is score on this scale., Baseline and every 2 weeks for 6 weeks|Change From Baseline in Smell Threshold Test Score at 6 Weeks, This test determined the lowest concentration of an odor compound that is perceivable by study participants. Scores on this test scale range between -2 and -10. Higher score indicates higher smell detection threshold (i.e. worse ability to smell). Total scores are reported on this scale (no sub-scales). The unit is score on this scale., Baseline and every 2 weeks for 6 weeks | Secondary: Change From Baseline in Plasma Theophylline Level at 6 Weeks, Plasma levels of theophylline were measured using fluorescence polarization technique. Minimum level will be 0 microgram/mL and maximum assay limit is 40 microgram/mL. Higher levels indicate increased systemic exposure to theophylline. Units on scale are microgram/mL., Baseline and every 2 weeks for 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Massachusetts General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-10
|
| Completion Date: |
2022-07
|
| Results First Posted: |
2024-01-09
|
| Last Update Posted: |
2024-01-09
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02479451
|
