The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

Tinnitus Clinical Trial

— Aktin  

Official title:

The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226108
• Other study ID #: Aktin study
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: September 23, 2011
• Start date: October 2010

Study information

• Verified date: September 2011
• Source: Akloma Bioscience AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Patch
One patch per day, Duration: three weeks, Administration: behind the ear

Locations

Country	Name	City	State
Sweden	Sickla ÖNH-center, Atlashuset Planiavägen 5	Nacka

Sponsors (1)

Lead Sponsor	Collaborator
Akloma Bioscience AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		7 weeks	No
Primary	Tinnitus severity questionnaire score as a measure of efficacy		3 weeks	No