Pilot Study of OXP001 and Brufen in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT02050958|
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : April 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|NSAID Related Gastric Irritation||Drug: OXP001 Drug: Ibuprofen||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomised, Open Label, Evaluator Blinded, Multiple Dose, Parallel Arm, Phase I Pilot Study of OXP001 Ibuprofen 400 mg Tablets and Brufen 400 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions to Assess The Incidence of Upper Gastrointestinal Irritation|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: Ibuprofen
Other Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050958
|Nottingham, United Kingdom|
|Principal Investigator:||Stuart Mair, MB ChB||Quotient Clinical Ltd|