Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

--------------------------------------------------------------------------------


  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014