Canadian Active & Maintenance Modified Pentasa Study

01:03 EDT 21st April 2015 | BioPortfolio

Summary

The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis and also in maintenance of quiescent disease.

Description

A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Conditions

Active Ulcerative Colitis

Intervention

5-ASA (5-Aminosalicylate), 5-ASA (5-Aminosalicylate)

Location

University of Calgary, Faculty of Medicine
Calgary
Alberta
Canada

Status

Recruiting

Source

Ferring Pharmaceuticals

Results (where available)

View Results

Links

Clinical Trials [241 Associated Clinical Trials listed on BioPortfolio]

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with act...

Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will ...

Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

Asacol™ 4.8 g/day (800 mg tablets) is statistically significant more effective to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with...

A Study of Abatacept in Patients With Active Ulcerative Colitis

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other ...

Asacol Dosing Study for Active Ulcerative Colitis

We, the investigators at University of Washington, plan on evaluating the effect of open label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per day) on...

PubMed Articles [5984 Associated PubMed Articles listed on BioPortfolio]

Association Between Serum Concentration of Infliximab and Efficacy in Adult Patients with Ulcerative Colitis.

We analyzed data collected during the Active Ulcerative Colitis Trials (ACT-1 and ACT-2) to assess relationships between serum concentrations of infliximab and outcomes of adults with moderate-to-seve...

Surgical management of patients with ulcerative colitis during pregnancy: Maternal and fetal outcomes.

Ulcerative colitis can develop during the reproductive years, and there are limited data about perinatal care for patients with ulcerative colitis. In this study, we analyzed perinatal follow-up, comp...

NONSPECIFIC ULCERATIVE COLITIS IN COMBINATION WITH RHEUMATOID ARTHRITIS (CASE REPORT).

The rheumatoid arthritis in the structure of rheumatological diseases occupies about 10% and is one of the most widespread inflammatory diseases of joints. The joint damage often meeting by the nonspe...

Treatment of severe ulcerative colitis flares.

The treatment of severe ulcerative colitis remains a challenge for gastroenterologists. A not inconsiderable number of patients will experience severe flares throughout their lives and will require ho...

Multidrug resistance gene and its relationship to ulcerative colitis and immune status of ulcerative colitis.

We examined the relationship among the multidrug resistance (MDR1) gene product P-glycoprotein (P-gp), ulcerative colitis, and immune status under ulcerative colitis. MDR1 P-gp expression and interleu...

Medical and Biotech [MESH] Definitions

Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.

An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.

A surgical procedure involving the excision of the COLON and RECTUM and the formation of an ILEOANAL RESERVOIR (pouch). In patients with intestinal diseases, such as ulcerative colitis, this procedure avoids the need for an OSTOMY by allowing for transanal defecation.

A condition characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. This syndrome was first described in 1980 by Read and associates. Subtypes include COLLAGENOUS COLITIS and LYMPHOCYTIC COLITIS. Both have similar clinical symptoms and are distinguishable only by histology.

More From BioPortfolio on "Canadian Active & Maintenance Modified Pentasa Study"

Search BioPortfolio:
Loading
Advertisement
Advertisement

Searches Linking to this Trial