Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Ulcers; NSAID-induced Gastroduodenal Injury
• Intervention / Treatment: Drug: Placebo; Drug: Non-steroidal anti-inflammatory drug; Drug: Cobiprostone

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Carl T Hayden VA Medical Center
  • California
    • Chula Vista, California, United States, 91910
      • Gregory J. Wiener, MD PC
    • Loma Linda, California, United States, 92354
      • Loma Linda University Physicians Medical Group
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Palm Springs, California, United States, 92262
      • Desert Oasis Healthcare
    • Sepulveda, California, United States, 91343
      • Sepulveda Ambulatory Care Center
  • Florida
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Medical Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Gulf Coast Research, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group
    • New York, New York, United States, 10021
      • Research Associates of New York
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Gastroenterology
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Founddation for Digestive Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Philadelphia, Pennsylvania, United States, 19140
      • Gastroenterology Section at Temple University Hospital
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Research Corporation, Inc.
    • Houston, Texas, United States, 77074
      • Houston Institute For Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants receive matching placebo capsules for 20 months	Drug: Placebo; Matching placebo capsules for oral administration; Other Names: Matching Placebo; Drug: Non-steroidal anti-inflammatory drug; Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.; Other Names: Standard Care
Experimental: Cobiprostone QD; Participants receive 18 mcg cobiprostone once daily (QD) for 20 months	Drug: Non-steroidal anti-inflammatory drug; Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.; Other Names: Standard Care; Drug: Cobiprostone; 18 mcg cobiprostone capsules for oral administration; Other Names: SPI-8811; RU-8811
Experimental: Cobiprostone BID; Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months	Drug: Non-steroidal anti-inflammatory drug; Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.; Other Names: Standard Care; Drug: Cobiprostone; 18 mcg cobiprostone capsules for oral administration; Other Names: SPI-8811; RU-8811
Experimental: Cobiprostone TID; Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months	Drug: Non-steroidal anti-inflammatory drug; Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.; Other Names: Standard Care; Drug: Cobiprostone; 18 mcg cobiprostone capsules for oral administration; Other Names: SPI-8811; RU-8811

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Gastric Ulcers	at 20 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Duodenal and Gastroduodenal Ulcers	at 20 months
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers	at Week 4
Size of Ulcers/Erosions	at 20 Months

Collaborators and Investigators

• Sponsor: Sucampo Pharma Americas, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 10, 2008
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (Estimate): January 18, 2008

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Wounds and Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: SU0621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No