Trial · NCT02040194
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI) | Baseline to Day 84 | Improvement in TFI total score |
| Primary | Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest) | Baseline to Day 84 | Improvement in TLQ NRS loudest |
| Primary | Safety endpoint: Hearing threshold | Baseline to Day 35 | Occurrence of deterioration in hearing threshold \>= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s) |
| Secondary | Efficacy endpoint - TFI | Baseline to Day 10 and Day 35 | Improvement in TFI total score |
| Secondary | Efficacy endpoint - TLQ NRS loudest | Baseline to Day 10 and Day 35 | Improvement in patient-reported tinnitus loudness |
| Secondary | Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst) | Baseline to Day10, Day 35 and Day 84 | Improvement in TAQ NRS worst |
| Secondary | Efficacy endpoint - TFI sleep score | Baseline to Day10, Day 35 and Day 84 | Improvement in TFI sleep score. The subscale "sleep" will be evaluated only for subjects with a TFI Sleep score greater than 0 at baseline. |
| Secondary | Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus) | at Day10, Day 35 and Day 84 | Patient global impression of change in tinnitus severity |
| Secondary | Safety endpoint - Hearing threshold | Baseline to Day 1, Day 2, Day 10 and Day 84 | Occurrence of deterioration in hearing threshold \>= 15 dB at the average of two contiguous test frequencies in the treated ear(s) |
| Secondary | Safety endpoint - Hearing threshold | Baseline to Day 1, Day 2, Day 10 and Day 84 | Difference in occurrence of deterioration in hearing threshold \>= 15 dB at the average of two contiguous test frequencies between the treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only) |
| Secondary | Safety endpoint - AEs and SAEs | Up to Day 84 | Occurence and severity of adverse events (AEs) and serious adverse Events (SAEs), differentiated by relatedness, and by treatment-emergence and procedure-emergence |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02040194/registered