Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Dr. Falk Pharma

Status and phase: Completed; Phase 3

Conditions: Lymphocytic Colitis

Treatments: Drug: Mesalamine; Other: Placebo; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01209208

2008-005994-36 (EudraCT Number)

BUG-1/LMC

Details and patient eligibility

About

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.

Enrollment: 57 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Symptoms and signs of indication of lymphocytic colitis

Exclusion criteria

• Infectious diarrhoea,
• Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
• Pregnancy or breast-feeding,
• Participation in an other clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

57 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Budesonide

Treatment:

Drug: Budesonide

B

Experimental group

Description:

Mesalazine

Treatment:

Drug: Mesalamine

C

Placebo Comparator group

Treatment:

Other: Placebo