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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
NSAID Related Gastric Irritation Drug: OXP001 Drug: Ibuprofen Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Primary Completion Date : March 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: OXP001
OXP001
Drug: OXP001
Active Comparator: Ibuprofen
Brufen
Drug: Ibuprofen
Other Name: Brufen


Outcome Measures

Primary Outcome Measures :
  1. Gastric irritation as measured by a Lanza score [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United Kingdom
Quotient Clinical
Nottingham, United Kingdom
Sponsors and Collaborators
Oxford Pharmascience Ltd
Investigators
Principal Investigator: Stuart Mair, MB ChB Quotient Clinical Ltd
More Information

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02050958     History of Changes
Other Study ID Numbers: OXP001-002
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action