Drug-induced Ototoxicity in Peritoneal Dialysis PatientsPhase 2NCT01131468
Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
A Phase 2 study testing N-acetylcysteine in people with Drug-induced Ototoxicity in Peritoneal Dialysis Patients, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drug-induced Ototoxicity in Peritoneal Dialysis Patients
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2008to May 2010
- Phase
- Phase 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
- End-stage renal disease
- Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
- Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode
Who cannot join
- Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
- Detection of mechanical occlusion of external ear
- Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
- History of a continuous ambulatory peritoneal dialysis related peritonitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University School of Medicine Department of Nephrology
Kayseri, 38039
About this study
Official title: The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.
- Being tested
- N-acetylcysteine
- Keywords
- ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis
- Medical subject headings
- Ototoxicity, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin Receives: Drug: N-acetylcysteine |
| Controls | No intervention | Vancomycine and/or amikacin alone Receives: Drug: N-acetylcysteine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startFeb 2008
- Primary completionApr 2010
- Study completionMay 2010
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 Drug-induced Ototoxicity in Peritoneal Dialysis PatientsStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Investigators
- Bulent Tokgoz, MD, Principal investigator, Erciyes University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131468
- Sponsor's protocol ID
- OTOTOXICITY RESEARCH IN PD
- Status last verified
- Mar 2010
- First submitted
- 17 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
Publications
Tokgoz B, Ucar C, Kocyigit I, Somdas M, Unal A, Vural A, Sipahioglu M, Oymak O, Utas C. Protective effect of N-acetylcysteine from drug-induced ototoxicity in uraemic patients with CAPD peritonitis. Nephrol Dial Transplant. 2011 Dec;26(12):4073-8. doi: 10.1093/ndt/gfr211. Epub 2011 May 6.
PubMed 21551083
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01131468
- Acronym / sponsor ID
- OTOTOXICITY RESEARCH IN PD
- Keywords
- ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 May 2010 (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 N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetylcysteineN-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin |
| Controls | No intervention | Drug: N-acetylcysteineVancomycine and/or amikacin alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End-stage renal disease
- Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
- Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode
Key exclusion criteria (4 listed)
- Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
- Detection of mechanical occlusion of external ear
- Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
- History of a continuous ambulatory peritoneal dialysis related peritonitis
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 |
|---|---|---|
| N-acetylcysteineN-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone | Drug | Controls, N-acetylcysteine |
Primary outcome
Not reported in the source record.
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 27 May 2010.
- Derived from this study: PubMed 21551083Tokgoz B, Ucar C, Kocyigit I, Somdas M, Unal A, Vural A, Sipahioglu M, Oymak O, Utas C. Protective effect of N-acetylcysteine from drug-induced ototoxicity in uraemic patients with CAPD peritonitis. Nephrol Dial Transplant. 2011 Dec;26(12):4073-8. doi: 10.1093/ndt/gfr211. Epub 2011 May 6.
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.
Bulent Tokgoz, MD principal investigator
Erciyes University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Drug-induced Ototoxicity in Peritoneal Dialysis Patients, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01131468, 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 27 May 2010.