Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2011-005384-24-BE
EUCTR2011-005384-24-BEActive, not recruitingPhase 1

TACTT1 - TACTT1

Auris Medical AG0 sites72 target enrollmentStarted: November 29, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
72
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •A subject will be eligible for inclusion in this study if all of the following criteria apply:
  • •1. Persistent tinnitus (unilateral or bilateral) following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotraumas with onset up to three months ago (i.e. acute tinnitus), as documented by medical report.
  • •2. Age = 18 years and = 65 years.
  • •3. Negative pregnancy test for women of childbearing potential.
  • •4. Willing and able to attend the study visits.
  • •5.Able to read and understand study documents, and investigator instructions.
  • •6. Signed IEC (Independent Ethics Committee)-approved Informed Consent Form.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 72
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • •1. Fluctuating Tinnitus.
  • •2. Intermittent Tinnitus.
  • •3. Menière's Disease.
  • •4. Ongoing acute or chronic Otitis media or Otitis externa.
  • •5. Any drug-based therapy for Otitis media that is ongoing or was performed in the past 2 weeks.
  • •6. Any therapy known as potentially Tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin [> 5 adult doses/day] or quinine) in the past 2 weeks or that is ongoing or planned for the study duration.
  • •7. Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxyfilline, betahistine, diazepam, car-bamazepine, sodium valproate and antidepressants.
  • •8. Use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan) in the past 2 weeks, or that is ongoing, or that is planned for the study duration.
  • •9. Any ongoing or planned treatment of Tinnitus for the study duration.
  • •10. History within the past two years or presence of drug abuse or alcoholism.
  • •11. Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder, as determined by the Investigator.
  • •12. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction.
  • •13. Women who are breast-feeding, pregnant or who are planning to become pregnant during the trial.
  • •14. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months.
  • •15. Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry.

Investigators

Similar Trials

Active, not recruiting
Not Applicable
Administration of a single dose or of three doses of AM-101to patients with Tinnitus (Ringing in the Ears) and comparision of both doses.Acute inner ear tinnitus following acute acustic trauma, acute otitis media, middle ear surgery, or inner ear barotraumaMedDRA version: 14.1Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disorders
EUCTR2011-005384-24-DEAuris Medical AG72
Active, not recruiting
Not Applicable
/ACerebral venous thrombosis
EUCTR2010-020302-15-PTIMM - Instituto de Medicina Molecular164
Recruiting
Phase 1
A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects with Advanced Solid Tumors
CTIS2022-500849-24-00Tolremo Therapeutics AG25
Recruiting
Phase 1
An open-label, phase I/II study of T3P-Y058-739, a genetically-modified strain of the bacterium Yersinia enterocolitica, in patients with advanced solid tumours
CTIS2023-504199-19-00T3 Pharmaceuticals AG100
Recruiting
Phase 1
Safety and Tolerability of AC01 in patients with heart failureMedDRA version: 20.0Level: LLTClassification code: 10078289Term: Heart failure with reduced ejection fraction Class: 10007541Heart Failure
CTIS2022-500347-20-00Anacardio AB116