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Pilot Study of OXP005 to Assess Gastroduodenal Irritation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02408978
First Posted: April 6, 2015
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oxford Pharmascience Ltd
  Purpose
Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at the relative impact of both products on gastroduodenal (GD) irritation 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.

Condition Intervention Phase
Gastroduodenal Erosions Drug: OXP005 Drug: Naproxen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Oxford Pharmascience Ltd:

Primary Outcome Measures:
  • Severity of GD irritation in the stomach and duodenum as measured by the Lanza score [ Time Frame: Day 8 ]
  • Total number of GD erosions overall [ Time Frame: Day 8 ]

Study Start Date: May 2015
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OXP005
1g naproxen
Drug: OXP005
Active Comparator: naproxen
1g naproxen
Drug: Naproxen

  Eligibility

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 male or female subject
  • Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum)
  • H. pylori negative

Exclusion Criteria:

  • Clinically significant abnormal laboratory parameters
  • Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, centralcnervous, immunological, dermatological, GI or any other body system
  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): NCT02408978


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

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02408978     History of Changes
Other Study ID Numbers: OXP005-002
First Submitted: March 31, 2015
First Posted: April 6, 2015
Last Update Posted: June 18, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Naproxen
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
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action