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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receive matching placebo capsules for 20 months |
|
| Cobiprostone QD | Experimental | Participants receive 18 mcg cobiprostone once daily (QD) for 20 months |
|
| Cobiprostone BID | Experimental | Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months |
|
| Cobiprostone TID | Experimental | Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cobiprostone | Drug | 18 mcg cobiprostone capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Gastric Ulcers | at 20 months |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl T Hayden VA Medical Center | Phoenix | Arizona | 85012 | United States | ||
| Gregory J. Wiener, MD PC |
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Of 124 participants recruited, only 121 were actually enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo |
| FG001 | 18 mcg | Cobiprostone 18 mcg once daily (QD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching placebo capsules for oral administration |
|
|
| Non-steroidal anti-inflammatory drug | Drug | Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care. |
|
|
| Size of Ulcers/Erosions |
| at 20 Months |
| Chula Vista |
| California |
| 91910 |
| United States |
| Loma Linda University Physicians Medical Group | Loma Linda | California | 92354 | United States |
| Facey Medical Foundation | Mission Hills | California | 91345 | United States |
| Desert Oasis Healthcare | Palm Springs | California | 92262 | United States |
| Sepulveda Ambulatory Care Center | Sepulveda | California | 91343 | United States |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States |
| University of Illinois Medical Center | Chicago | Illinois | 60612 | United States |
| Gulf Coast Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | United States |
| Research Associates of New York | New York | New York | 10021 | United States |
| University of North Carolina Gastroenterology | Chapel Hill | North Carolina | 27599 | United States |
| Oklahoma Founddation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Gastroenterology Section at Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Dallas VA Research Corporation, Inc. | Dallas | Texas | 75216 | United States |
| Houston Institute for Clinical Research | Houston | Texas | 77074 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| FG002 |
| 36 mcg |
Cobiprostone 18 mcg twice daily (BID) |
| FG003 | 54 mcg | Cobiprostone 18 mcg three times daily (TID) |
| COMPLETED |
|
| NOT COMPLETED |
|
All subjects recruited were included in the baseline analysis set. Of the 124 participants recruited, only 121 were actually enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo |
| BG001 | Cobiprostone QD | Cobiprostone 18 mcg once daily (QD) |
| BG002 | Cobiprostone BID | Cobiprostone 18 mcg twice daily (BID) |
| BG003 | Cobiprostone TID | Cobiprostone 18 mcg three times daily (TID) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Gastric Ulcers | Intention to treat (ITT) population, defined as all participants enrolled in the trial | Posted | Count of Participants | Participants | at 20 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Duodenal and Gastroduodenal Ulcers | ITT | Posted | Count of Participants | Participants | at 20 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers | ITT | Posted | Count of Participants | Participants | at Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Size of Ulcers/Erosions | ITT | Posted | Mean | Standard Deviation | mm | at 20 Months |
|
|
All participants were treated and followed for ulcers and other adverse events for a total of 20 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo | 22 | 30 | 20 | 30 | ||
| EG001 | Cobiprostone QD | Cobiprostone 18 mcg once daily (QD) | 23 | 30 | 18 | 30 | ||
| EG002 | Cobiprostone BID | Cobiprostone 18 mcg twice daily (BID) | 25 | 31 | 22 | 31 | ||
| EG003 | Cobiprostone TID | Cobiprostone 18 mcg three times daily (TID) | 26 | 30 | 21 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal tract mucosal discolouration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Erosive Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Pain Other | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Reflux oesphagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | 5 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D014456 | Ulcer |
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C581134 | cobiprostone |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
|