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OpenTrials
Completed

NCT Number: NCT00597818

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

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Key information

Conditions

NSAID-induced Gastroduodenal Injury Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Ulcer Ulcers

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Carl T Hayden VA Medical Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is more than 40 and less than 70 years of age.
  • Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
  • No current gastrointestinal H. pylori infection.

Exclusion criteria

  • Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated condition(s) to NSAID therapy.
  • Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
  • Medical history includes prior or active GI complications and/or disorders, including but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD).
  • Active symptomatic peptic ulcer disease or GI bleeding.
  • Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.

Treatment and study plan

Cobiprostone

Drug

18 mcg cobiprostone capsules for oral administration

Other names: SPI-8811, RU-8811

Placebo

Drug

Matching placebo capsules for oral administration

Other names: Matching Placebo

non-steroidal anti-inflammatory drug

Drug

Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Other names: Standard Care

Primary outcomes

  1. Number of Participants With Gastric Ulcers

    Time frame: at 20 months

Secondary outcomes

  1. Number of Participants With Duodenal and Gastroduodenal Ulcers

    Time frame: at 20 months

  2. Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers

    Time frame: at Week 4

  3. Size of Ulcers/Erosions

    Time frame: at 20 Months

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Registry information

Official study title

A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2008
Registry last updated
Dec 26, 2019

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.

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