Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Sucampo

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis; NSAID-induced Gastroduodenal Injury; Ulcers; Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Non-steroidal anti-inflammatory drug; Drug: Cobiprostone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00597818

SU0621

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants receive matching placebo capsules for 20 months

Treatment:

Drug: Non-steroidal anti-inflammatory drug

Drug: Placebo

Cobiprostone QD

Experimental group

Description:

Participants receive 18 mcg cobiprostone once daily (QD) for 20 months

Treatment:

Drug: Non-steroidal anti-inflammatory drug

Drug: Cobiprostone

Cobiprostone BID

Experimental group

Description:

Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months

Treatment:

Drug: Non-steroidal anti-inflammatory drug

Drug: Cobiprostone

Cobiprostone TID

Experimental group

Description:

Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months

Treatment:

Drug: Non-steroidal anti-inflammatory drug

Drug: Cobiprostone