A Phase 3 interventional study of Azithromycin in Trachoma, sponsored by Laboratoires Thea. Completed. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2006-07-26.
Sponsored by Laboratoires Thea · Phase 3, Interventional, and Treatment
To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure at Day 60 in Per Protocol Set), microbiological evaluation was secondary
The aim of the present study was to compare the efficacy of the dosing regimen which was demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment (T1225 1.5% eye drops BID for 3 days) with a shorter duration of treatment (T1225 1.5% eye drops BID for 2 days) and with a single oral administration of AZM (20 mg/kg) in patients suffering from active trachoma. The study was to be performed in approximately 600 children (aged 1 to 10 years) from Guinea Conakry and Pakistan.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
Browse Trachoma studies →Laboratoires Thea is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Clinically significant
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Hypersensitivity
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Immunosuppression
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Corticosteroids (steroids)
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Cure at end of study, i.e. TF0 grade on simplified WHO trachoma grading system < 5 follicles ≥ 0.5 mm diameter in upper tarsal conjunctiva) in the worse eye
at the end of the study
Cure at Days 30 and 60,
cure in both eyes,
trachoma grades at each visit;
microbiological cure;
Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation;
Global efficacy assessment by investigator.
Tolerance
No study locations are listed for this record.
This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin