Short-term Effects of Oxytocin Nasal Spray on Chronic Tin... | NCT02508220

Studies
Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

NCT02508220

Sponsor

Berthold Langguth, MD, Ph.D.

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Chronic Tinnitus

Interventions

Syntocinon
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Mar 18, 2015

First Submission Date that Met QC Criteria

Jul 23, 2015

First Posted Date

Jul 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Berthold Langguth, MD, Ph.D., Chair of the Tinnitus centrum Regensburg, University of RegensburgSponsor-Investigator

Lead Sponsor

Berthold Langguth, MD, Ph.D.OTHER

Collaborators

Name	Class
Otosul -Otorrinolaringologia Sul-Fluminense	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxy-Placebo	Other	Syntocinon first, Placebo second 2 puffs in each nostril	Drug: Syntocinon Drug: Placebo
Placebo-Oxy	Other	Placebo first, Syntocinon second 2 puffs in each nostril	Drug: Syntocinon Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Syntocinon	Drug	Oxytocin nasal spray	Oxy-Placebo Placebo-Oxy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of tinnitus on VAS		30 minutes after intervention
Change of Clinical global impression scale		30 minutes after intervention

Secondary Outcomes

Measure	Description	Time Frame
Audiometry measured in dB HL	measured in dB HL	within one hour before intervention
Minimum Masking Level measured in dB HL	measured in dB HL

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic tinnitus with a duration > 6 months
medical examination by an ENT specialist
sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires
VAS score >4 points

Exclusion Criteria:

vascular tinnitus
muscular tinnitus
conductive hearing loss
previous experience with oxytocin nasal spray
additional medications during the intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

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Browse Branches

Not provided