UMIN ID: UMIN000002112
Registered date:01/07/2009
Healing Effect of Gastric mucosal Lesion of patient with Osteoarthritis or Rheumatism by Cox2-Inhibitor and Anti ulcer agent(Rebamipide) combination therapy.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | rheumatic arthritis osteoarthritis lumbago |
| Date of first enrollment | 2009/07/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Administration of celecoxib Combined administration of celecoxib and rebamipide |
Outcome(s)
| Primary Outcome | An incidence of gastrointestinal bleeding or endoscopic ulcer |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | History of gastrointestinal surgery Presence of gastroesophageal reflex disease (GERD) Presence of malignancy Presence of gastrointestinal bleeding or gastrointestinal ulcer Presence of aspirin-induced asthma Pcesence of severe cardiac disorder, renal disorder or liver disorder Impossibility of endoscopic examination Presence of allergy of celecoxib or rebamipide History of percutaneous coronary revascularization Pregnancy and lactation Impossibility of discontinuation of proton pump inhibitor or histamine-2 receptor antagonist Administration of NSAID that excludes aspirin Patient who doctor judged improper |
Related Information
| Primary Sponsor | Department of Orthopaedic Surgery, Mie University Hospital Department of Gastroenterology and Hepatology, Mie University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Orthopaedic Surgery, Mie University Hospital Department of Gastroenterology and Hepatology, Mie University Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kyosuke Tanaka |
| Address | Japan |
| Telephone | |
| Affiliation | Mie University Hospital Gastroenterology and Hepatology |
| scientific contact | |
| Name | Masahiro Hasegawa |
| Address | 2-174 Edobashi, Tsu, Mie Japan Japan |
| Telephone | 059-232-1111 |
| Affiliation | Mie University Hospital Orthopaedic Surgery |