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Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Primary Purpose

NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cobiprostone
Placebo
Non-steroidal anti-inflammatory drug
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSAID-induced Gastroduodenal Injury

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Carl T Hayden VA Medical Center
  • Gregory J. Wiener, MD PC
  • Loma Linda University Physicians Medical Group
  • Facey Medical Foundation
  • Desert Oasis Healthcare
  • Sepulveda Ambulatory Care Center
  • University Clinical Research, Inc.
  • University of Illinois Medical Center
  • Gulf Coast Research, LLC
  • Boston Medical Center
  • Long Island Gastrointestinal Research Group
  • Research Associates of New York
  • University of North Carolina Gastroenterology
  • Oklahoma Founddation for Digestive Research
  • Altoona Center for Clinical Research
  • Gastroenterology Section at Temple University Hospital
  • Dallas VA Research Corporation, Inc.
  • Houston Institute for Clinical Research
  • Digestive and Liver Disease Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Cobiprostone QD

Cobiprostone BID

Cobiprostone TID

Arm Description

Participants receive matching placebo capsules for 20 months

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Gastric Ulcers

Secondary Outcome Measures

Number of Participants With Duodenal and Gastroduodenal Ulcers
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
Size of Ulcers/Erosions

Full Information

First Posted
January 10, 2008
Last Updated
December 10, 2019
Sponsor
Sucampo Pharma Americas, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00597818
Brief Title
Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive matching placebo capsules for 20 months
Arm Title
Cobiprostone QD
Arm Type
Experimental
Arm Description
Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Arm Title
Cobiprostone BID
Arm Type
Experimental
Arm Description
Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Arm Title
Cobiprostone TID
Arm Type
Experimental
Arm Description
Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Intervention Type
Drug
Intervention Name(s)
Cobiprostone
Other Intervention Name(s)
SPI-8811, RU-8811
Intervention Description
18 mcg cobiprostone capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Matching placebo capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Non-steroidal anti-inflammatory drug
Other Intervention Name(s)
Standard Care
Intervention Description
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Primary Outcome Measure Information:
Title
Number of Participants With Gastric Ulcers
Time Frame
at 20 months
Secondary Outcome Measure Information:
Title
Number of Participants With Duodenal and Gastroduodenal Ulcers
Time Frame
at 20 months
Title
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
Time Frame
at Week 4
Title
Size of Ulcers/Erosions
Time Frame
at 20 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Carl T Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Gregory J. Wiener, MD PC
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Loma Linda University Physicians Medical Group
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Desert Oasis Healthcare
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Sepulveda Ambulatory Care Center
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Gulf Coast Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of North Carolina Gastroenterology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Oklahoma Founddation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Gastroenterology Section at Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Dallas VA Research Corporation, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Houston Institute for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

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