A Phase 4 interventional study of Acetylcysteine and Placebo (NaCl) in Otosclerosis, sponsored by Karolinska University Hospital. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-11.
Sponsored by Karolinska University Hospital · Phase 4, Interventional, and Treatment
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.
25 studies on the registry are indexed under Otosclerosis; 5 are open to participants now.
This study's enrollment of 152 is above the median of 32 across 11 interventional studies indexed under Otosclerosis.
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Exclusion Criteria:
Drug: Acetylcysteine
Drug: Placebo (NaCl)
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.
300 mL 0.9% NaCl
Hearing thresholds
Time frame: one year
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetylcysteine
Karolinska University Hospital →