Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

• Proportion of patients developing duodenal and gastroduodenal ulcers [ Time Frame: Overall ] [ Designated as safety issue: No ]
• Proportion of patients developing gastric, duodenal, and gastroduodenal ulcers [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
• Change in number of ulcers by patient [ Time Frame: Overall ] [ Designated as safety issue: No ]
• Change in number of erosions by patient [ Time Frame: Overall ] [ Designated as safety issue: No ]
• Size of ulcers/erosions [ Time Frame: Overall ] [ Designated as safety issue: No ]
• Time-to-onset of ulcer/erosion development [ Time Frame: Overall ] [ Designated as safety issue: No ]
• Lanza assessment of gastroduodenal injury [ Time Frame: Weeks 4, 8, 12, and overall ] [ Designated as safety issue: No ]
• Analysis of dyspepsia/dyspeptic symptoms [ Time Frame: Weekly and overall ] [ Designated as safety issue: No ]

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.

• NSAID-induced Gastroduodenal Injury
• Ulcers
• Rheumatoid Arthritis
• Osteoarthritis

• Drug: Cobiprostone
  6 mcg and 12 mcg capsules
  Other Name: SPI-8811
• Drug: Placebo
  0 mcg capsules

• Placebo Comparator: 1
  Intervention: Drug: Placebo
• Experimental: 2
  Cobiprostone 18 mcg once daily (QD)
  Intervention: Drug: Cobiprostone
• Experimental: 3
  Cobiprostone 18 mcg twice daily (BID)
  Intervention: Drug: Cobiprostone
• Experimental: 4
  Cobiprostone 18 mcg three times daily (TID)
  Intervention: Drug: Cobiprostone

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 (lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.