Hearing LossPhase 1/2NCT01621256
Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
A Phase 1/2 study testing Ancrod and Saline solution in people with Hearing Loss and Deafness, run by Nordmark Arzneimittel GmbH & Co. KG at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hearing Loss, Deafness, Hearing Loss, Sensorineural
- What is being tested?
- Ancrod and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 7 sitesin 2 countries
- Study dates
- May 2013to 30 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
- Symmetric hearing prior to onset of SSHL
- Enrollment has to be accomplished within 7 days after SSHL onset
Who cannot join
- Bilateral SSHL
- Incomplete recovery after previous SSHL
- Previously existing, known retrocochlear hearing loss
- Any history of any ear operation or local inflammatory disease in the past one year
- History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
- History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
- Treatment with steroids for any reason within the preceding 30 days.
- Body weight > 140 kg
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany5 sites
Site D
Göttingen
Site D
Hamburg
Site D
Hanover
Site D
Landsberg am Lech
Site D
München
About this study
Official title: Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
- Being tested
- Ancrod, Saline solution
- Medical subject headings
- Hearing Loss, Deafness, Hearing Loss, Sensorineural, Hearing Disorders, Ear Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AncrodDrug
Also called Viprinex, NM-V
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Saline solutionDrug
Also called Placebo
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Ancrod | Experimental | Ancrod Receives: Drug: Ancrod |
| Saline solution | Placebo comparator | Saline solution Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTA (pure tone audiogram) in the affected ear
Measured: From baseline to Day 8
Secondary outcomes (1)
Change in speech recognition in the affected ear
Measured: From baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMay 2013
- Primary completion18 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordmark Arzneimittel GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSupport GmbH, MWI Medizinisches Wirtschaftsinstitut GmbH, ProjectPharm s.r.o., LCR Leading Clinical Research s.r.o., X-act Cologne Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Martin Canis, MD PhD, Principal investigator, Department for Otorhinolaryngology, LM University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621256
- Sponsor's protocol ID
- NM-V-101
- Other IDs
- 2012-000066-37
- Status last verified
- Dec 2018
- First submitted
- 12 Jun 2012
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)
- ClinicalTrials.gov ID
- NCT01621256
- Acronym / sponsor ID
- NM-V-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Nordmark Arzneimittel GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- ClinSupport GmbH, MWI Medizinisches Wirtschaftsinstitut GmbH, ProjectPharm s.r.o., LCR Leading Clinical Research s.r.o., X-act Cologne Clinical Research GmbH
- Study start
- May 2013
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ancrod | Experimental | Drug: AncrodAncrod |
| Saline solution | Placebo comparator | Drug: Saline solutionSaline solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
- Symmetric hearing prior to onset of SSHL
- Enrollment has to be accomplished within 7 days after SSHL onset
Key exclusion criteria (8 listed)
- Bilateral SSHL
- Incomplete recovery after previous SSHL
- Previously existing, known retrocochlear hearing loss
- Any history of any ear operation or local inflammatory disease in the past one year
- History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AncrodAlso: Viprinex, NM-VDay 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections | Drug | Ancrod |
| Saline solutionAlso: PlaceboDay 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections | Drug | Saline solution |
Primary outcome
Change in PTA (pure tone audiogram) in the affected ear
Time frame: From baseline to Day 8
1 secondary outcome
Change in speech recognition in the affected ear
Time frame: From baseline to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Canis, MD PhD principal investigator
Department for Otorhinolaryngology, LM University Munich
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ancrod and Saline solution in people with Hearing Loss and Deafness, run by Nordmark Arzneimittel GmbH & Co. KG at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTA (pure tone audiogram) in the affected ear (time frame: From baseline to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.