Pilot Study of OXP001 and Brufen in Healthy Subjects

NSAID Related Gastric Irritation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050958
• Other study ID #: OXP001-002
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2014
• Last updated: April 28, 2014
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Oxford Pharmascience Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

• Aged 18-55 years

• Normal, healthy upper gastrointestinal tract

Exclusion Criteria:

• History of or concurrent gastric irritation or ulcers

• History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSAID Related Gastric Irritation

Intervention

Drug:
• OXP001

• Ibuprofen

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Pharmascience Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric irritation as measured by a Lanza score		7 days	Yes
Secondary	Number of erosions		7 days	Yes
Secondary	Number of ulcers		7 days	Yes
Secondary	Incidence of gastric irritation		7 days	Yes
Secondary	Lanza score in stomach and duodenum		7 days	Yes