A Phase 1 interventional study of OXP001 and Ibuprofen in NSAID Related Gastric Irritation, sponsored by Oxford Pharmascience Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-30.
Sponsored by Oxford Pharmascience Ltd · Phase 1, Interventional, and Treatment
Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the study drug) which it is proposed will have less of the side effects than are currently reported with standard prescription strength Ibuprofen.
This study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically a gastroscopy). The safety and tolerability of the study drug will also be assessed.
The study will involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.
Oxford Pharmascience Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OXP001
Drug: OXP001
Brufen
Drug: Ibuprofen
Also known as: Brufen
Gastric irritation as measured by a Lanza score
Time frame: 7 days
Number of erosions
Time frame: 7 days
Number of ulcers
Time frame: 7 days
Incidence of gastric irritation
Time frame: 7 days
Lanza score in stomach and duodenum
Time frame: 7 days
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Oxford Pharmascience Ltd