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
  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)

Resource links provided by NLM:


Further study details as provided by Akloma Bioscience AB:

Primary Outcome Measures:
  • 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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226108

Locations
Sweden
Sickla ÖNH-center, Atlashuset Planiavägen 5
Nacka, Sweden, 131 34
Sponsors and Collaborators
Akloma Bioscience AB
Investigators
Principal Investigator: Peter Åhnblad Sickla ÖNH-center / Supramed AB
  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 April 16, 2014