This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Pilot Study of OXP001 and Brufen in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier:
NCT02050958
First received: January 29, 2014
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
NSAID Related Gastric Irritation Drug: OXP001 Drug: Ibuprofen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Oxford Pharmascience Ltd:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: February 2014
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OXP001
OXP001
Drug: OXP001
Active Comparator: Ibuprofen
Brufen
Drug: Ibuprofen
Other Name: Brufen

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 29, 2014
Last Updated: April 28, 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

ClinicalTrials.gov processed this record on July 21, 2017