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OpenTrials
Completed

NCT Number: NCT02050958

Pilot Study of OXP001 and Brufen in Healthy Subjects

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.

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Key information

Conditions

NSAID Related Gastric Irritation

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OXP001

Drug

Ibuprofen

Drug

Other names: Brufen

Primary outcomes

  1. Gastric irritation as measured by a Lanza score

    Time frame: 7 days

Secondary outcomes

  1. Number of erosions

    Time frame: 7 days

  2. Number of ulcers

    Time frame: 7 days

  3. Incidence of gastric irritation

    Time frame: 7 days

  4. Lanza score in stomach and duodenum

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Oxford Pharmascience Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2014
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.