The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (Aktin)
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Purpose
OBJECTIVES:
Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
Secondary Objectives
The secondary objective will be to:
To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.
METHODOLOGY
Study Design:
An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.
Treatment Duration:
1 patch per day for 3 weeks
Primary Endpoint:
Tinnitus severity questionnaire (TSQ)
Performance Parameters:
Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus annoyance.
Quality of life and sleep quality
Safety Parameters: Adverse Reactions
| Condition | Intervention |
|---|---|
|
Tinnitus |
Device: Patch |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study) |
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
- Tinnitus severity questionnaire score as a measure of efficacy [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | October 2010 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: antinitus patch
One patch per day, Duration: three weeks, Administration: behind the ear
|
Device: Patch
One patch per day, Duration: three weeks, Administration: behind the ear -------------------------------------------------------------------------------- |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults of both sexes > 18 years of age
- Signed informed consent
- Patients who have suffered from tinnitus for ≥ 4 weeks before study entry
- Manifested tinnitus grade II or above on the Klockhoff-Lindblom tinnitus severity grading scale.
- Tinnitus score of 5 or above (numerical rating scale for tinnitus annoyance)
- Pure tone averages better than 40 dB in the worse hearing ear.
Exclusion Criteria:
- Pregnant or lactating women
- Malignancy or other serious medical conditions
- Skin disease
- Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
- Severe psychiatric disorder
- Serious suicidal risk
- Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before study start.
- Patients with untreated high blood pressure ≥140/90 mmHg
- Other tinnitus treatment within 6 weeks before study entry.
- Previous use of the Antinitus patch
- Known allergy or sensitivity to any of the compounds in the Antinitus or the placebo patches.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Akloma Bioscience AB |
| ClinicalTrials.gov Identifier: | NCT01226108 History of Changes |
| Other Study ID Numbers: | Aktin study |
| Study First Received: | October 20, 2010 |
| Last Updated: | September 23, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013