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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akloma Bioscience AB
ClinicalTrials.gov Identifier:
NCT01226108
First received: October 20, 2010
Last updated: September 23, 2011
Last verified: September 2011

October 20, 2010
September 23, 2011
October 2010
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01226108 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinnitus
Device: Patch

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

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Active Comparator: antinitus patch
One patch per day, Duration: three weeks, Administration: behind the ear
Intervention: Device: Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Not Provided
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01226108
Aktin study
No
Akloma Bioscience AB
Akloma Bioscience AB
Not Provided
Principal Investigator: Peter Åhnblad Sickla ÖNH-center / Supramed AB
Akloma Bioscience AB
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP