OtosclerosisPhase 4NCT00525551
Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
A Phase 4 study testing Acetylcysteine in people with Otosclerosis, run by Karolinska University Hospital at 3 sites in Sweden.
Trial summary
In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis
- What is being tested?
- Acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 3 sitesSweden
- Study dates
- Sep 2007to Apr 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Otosclerosis where surgery is planned
- Air / bone gap larger than 20 dB
- Normal middle ear status
Who cannot join
- Hypersensitivity to acetylcysteine
- Deafness on the other ear
- Stapedotomy previously performed on the ear
- Pregnancy
- Asthma
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Karolinska University Hospital Huddinge
Huddinge, SE-141 86
Karolinska University Hospital, Dept. of Otorhinolaryngology
Stockholm, SE-171 76
Academic Hospital
Uppsala, SE-75185
About this study
Official title: Acetylcystein Vid Stapedotomi
In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.
Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.
- Conditions
- Otosclerosis
- Being tested
- Acetylcysteine, Placebo (NaCl)
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcysteineDrug
150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery.
Placebo (NaCl)Drug
300 mL 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Acetylcysteine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo (NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing thresholds
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, AstraZeneca
- Responsible party
- Principal investigator, Anders Fridberger, Karolinska University Hospital
- Investigators
- Dan Bagger-Sjoback, M.D.,Ph.D., Study chair, Karolinska University HospitalAnders Fridberger, M.D.,Ph.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525551
- Sponsor's protocol ID
- KS-OAS1
- Other IDs
- EudraCT 2006-006243-31
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2007
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bagger-Sjoback D, Stromback K, Hakizimana P, Plue J, Larsson C, Hultcrantz M, Papatziamos G, Smeds H, Danckwardt-Lilliestrom N, Hellstrom S, Johansson A, Tideholm B, Fridberger A. A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery. PLoS One. 2015 Mar 12;10(3):e0115657. doi: 10.1371/journal.pone.0115657. eCollection 2015.
PubMed 25763866
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetylcystein Vid Stapedotomi
- ClinicalTrials.gov ID
- NCT00525551
- Acronym / sponsor ID
- KS-OAS1
- Conditions
- Otosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, AstraZeneca
- Study start
- Sep 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Sep 2007 (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.
In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.
Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.
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 |
|---|---|---|
| 1 | Active comparator | Drug: Acetylcysteine |
| 2 | Placebo comparator | Drug: Placebo (NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Otosclerosis where surgery is planned
- Air / bone gap larger than 20 dB
- Normal middle ear status
Key exclusion criteria (5 listed)
- Hypersensitivity to acetylcysteine
- Deafness on the other ear
- Stapedotomy previously performed on the ear
- Pregnancy
- Asthma
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 |
|---|---|---|
| Acetylcysteine150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery. | Drug | 1 |
| Placebo (NaCl)300 mL 0.9% NaCl | Drug | 2 |
Primary outcome
Hearing thresholds
Time frame: one year
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 11 Sep 2013.
- Derived from this study: PubMed 25763866Bagger-Sjoback D, Stromback K, Hakizimana P, Plue J, Larsson C, Hultcrantz M, Papatziamos G, Smeds H, Danckwardt-Lilliestrom N, Hellstrom S, Johansson A, Tideholm B, Fridberger A. A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery. PLoS One. 2015 Mar 12;10(3):e0115657. doi: 10.1371/journal.pone.0115657. eCollection 2015.
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
Dan Bagger-Sjoback, M.D.,Ph.D. study chair
Karolinska University Hospital
Anders Fridberger, M.D.,Ph.D. principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetylcysteine in people with Otosclerosis, run by Karolinska University Hospital at 3 sites in Sweden.
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 5 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 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hearing thresholds (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525551, which also lists 1 linked publication.
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 11 Sep 2013.