Pilot Study of OXP001 and Brufen in Healthy Subjects
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
1 other identifier
interventional
43
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 30, 2014
April 1, 2014
28 days
January 29, 2014
April 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Gastric irritation as measured by a Lanza score
7 days
Secondary Outcomes (4)
Number of erosions
7 days
Number of ulcers
7 days
Incidence of gastric irritation
7 days
Lanza score in stomach and duodenum
7 days
Study Arms (2)
OXP001
EXPERIMENTALOXP001
Ibuprofen
ACTIVE COMPARATORBrufen
Interventions
Eligibility Criteria
You may qualify if:
- Healthy subjects
- Aged 18-55 years
- Normal, healthy upper gastrointestinal tract
You may not qualify if:
- History of or concurrent gastric irritation or ulcers
- History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Clinical
Nottingham, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Mair, MB ChB
Quotient Clinical Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
February 1, 2014
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
April 30, 2014
Record last verified: 2014-04