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Oral Budesonide-MMX 9mg Extended Release Tablets

2014-07-24 14:06:38 | BioPortfolio

Summary

This is an open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study).

Description

Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.

Study Design

Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Colitis, Ulcerative

Intervention

Budesonide MMX

Status

Enrolling by invitation

Source

Santarus

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:06:38-0400

Clinical Trials [609 Associated Clinical Trials listed on BioPortfolio]

(CB-01-02/01)Randomized Placebo Controlled Trial of Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg in Patients With Ulcerative Colitis

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if...

Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

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Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)

Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.

PubMed Articles [561 Associated PubMed Articles listed on BioPortfolio]

Budesonide Suppositories are Effective and Safe for Treating Acute Ulcerative Proctitis.

Though proctitis is the most limited form of ulcerative colitis, it causes unpleasant symptoms. Topical mesalamine, the standard treatment, is not always effective. We conducted a randomized phase 2 t...

Second-Look Endoscopy in Hospitalized Severe Ulcerative Colitis: A Retrospective Cohort Study.

Acute severe ulcerative colitis (ASUC) is a serious complication of ulcerative colitis (UC). Management of partial responders to steroids or rescue therapy remains challenging. Whether there is a role...

Decreased Serum Bilirubin Levels and Increased Uric Acid Levels are Associated with Ulcerative Colitis.

BACKGROUND In recent years, emerging evidence has suggested that ulcerative colitis occurs as a consequence of an imbalance between oxidative stress and antioxidant capacity. The objective of this stu...

Rhubarb Peony Decoction Ameliorates Ulcerative Colitis in Mice by Regulating Gut Microbiota to Restoring Th17/Treg Balance.

Rhubarb Peony Decoction (RPD) is a formula of traditional Chinese medicine chronicled in Jin Gui Yao Lve, commonly used to treat ulcerative colitis (UC). However, the underlying mechanism of RPD treat...

Tension-type headache in ulcerative colitis.

Tension-type headache is a very common disease with a high socio-economic impact as its lifetime prevalence is 30-78% in the general population. The incidence of inflammatory bowel diseases is continu...

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.

A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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 humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

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