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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Patch
Sponsored by
Akloma Bioscience AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sickla ÖNH-center, Atlashuset Planiavägen 5

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

antinitus patch

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Tinnitus severity questionnaire score as a measure of efficacy

Secondary Outcome Measures

Full Information

First Posted
October 20, 2010
Last Updated
September 23, 2011
Sponsor
Akloma Bioscience AB
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1. Study Identification

Unique Protocol Identification Number
NCT01226108
Brief Title
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
Acronym
Aktin
Official Title
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akloma Bioscience AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antinitus patch
Arm Type
Active Comparator
Arm Description
One patch per day, Duration: three weeks, Administration: behind the ear
Intervention Type
Device
Intervention Name(s)
Patch
Intervention Description
One patch per day, Duration: three weeks, Administration: behind the ear --------------------------------------------------------------------------------
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
7 weeks
Title
Tinnitus severity questionnaire score as a measure of efficacy
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Åhnblad
Organizational Affiliation
Sickla ÖNH-center / Supramed AB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sickla ÖNH-center, Atlashuset Planiavägen 5
City
Nacka
ZIP/Postal Code
131 34
Country
Sweden

12. IPD Sharing Statement

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The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

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