Last updated: 11/07/2018 13:27:29
A double-blind, placebo-controlled, randomised, phase III clinical trial to compare the efficacy of oral Augmentin SR 2000/125 to placebo given as a single dose as prophylaxis or twice daily over 5 days as treatment to reduce the infective and inflammatory complications after undergoing maxillofacial surgery for third mandibular molar removal.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A double-blind, placebo-controlled, randomised, phase III clinical trial to compare the efficacy of oral Augmentin SR 2000/125 to placebo given as a single dose as prophylaxis or twice daily over 5 days as treatment to reduce the infective and inflammatory complications after undergoing maxillofacial surgery for third mandibular molar removal.
Trial description: A double-blind, placebo-controlled, randomised, phase III clinical trial to compare the efficacy of oral Augmentin SR 2000/125 to placebo given as a single dose as prophylaxis or twice daily over 5 days as treatment to reduce the infective and inflammatory complications after undergoing maxillofacial surgery for third mandibular molar removal.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
J.Martinez Lacasa, J.Jimenez, V. Ferras, C.Garcia-Rey, M. Bosom, O Sola-Morales, L. Aguilar, J. Garau. A double blind, placebo controlled randomised, comparative Phase III clinical trial of pharmacokinetically enhanced amoxicillin/clavulanate 200/125mg, as prophylaxis or as treatment vs placebo for infectious and inflammatory morbidity after third mandibular molar removal. Abstracts from the 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, USA. September 2003, page 423, Abstract L-1384.
Medical condition
Infections, Bacterial
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
May 2001 to Invalid Date
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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