The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

NCT01226108 | Completed

• 1 other identifier: Aktin study
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  7 weeks

• Tinnitus severity questionnaire score as a measure of efficacy

  3 weeks

Study Arms (1)

antinitus patch

ACTIVE COMPARATOR

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

Device: Patch

Interventions

Patch DEVICE

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

antinitus patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akloma Bioscience AB: lead

Study Sites (1)

Sickla ÖNH-center, Atlashuset Planiavägen 5

Nacka, 131 34, Sweden

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Peter Åhnblad

  Sickla ÖNH-center / Supramed AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

SE (1)