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Pilot Study of OXP005 to Assess Gastroduodenal Irritation

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ClinicalTrials.gov Identifier: NCT02408978
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Oxford Pharmascience Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Gastroduodenal Erosions Drug: OXP005 Drug: Naproxen Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : May 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OXP005
1g naproxen
Drug: OXP005
Active Comparator: naproxen
1g naproxen
Drug: Naproxen



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


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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

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

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02408978     History of Changes
Other Study ID Numbers: OXP005-002
First Posted: April 6, 2015    Key Record Dates
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