Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

NCT00217022 | Terminated Phase 2 Results

• 3 other identifiers: 1132-03IRUSBUEN0002UL1RR024150
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.

Conditions

Lymphocytic Colitis; Diarrhea

Keywords

Lymphocytic Colitis; diarrhea; budesonide

Outcome Measures

Primary Outcomes (1)

• Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks

  Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.

  Three out of last four weeks that the subject was on the study

Secondary Outcomes (1)

• Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies

  Baseline (day 1 of study) and at eight weeks (approximately)

Study Arms (2)

Budesonide

ACTIVE COMPARATOR

9 mg daily

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

three tablets daily

Other: Placebo

Interventions

Placebo OTHER

Placebo, 3 tablets daily

Placebo

Budesonide DRUG

9 mg daily (three tablets)

Also known as: Entocort EC

Budesonide

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
• Lymphocytic colitis confirmed histologically within one year of enrollment

You may not qualify if:

• Previous unsuccessful treatment with corticosteroids or immunosuppressive drugs
• History of severe corticosteroid side effects
• Corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks
• Antibiotic, mesalamine or bismuth subsalicylate use within two weeks
• Current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice
• Known active medical conditions, including cancer, infection, uncontrolled hypertension or diabetes, osteoporosis, peptic ulcer disease, glaucoma, cataracts, liver cirrhosis or history of tuberculosis
• Other diarrheal conditions (sprue, infection, hyperthyroidism, lactose intolerance)
• Pregnant or nursing females
• Patients without a telephone or unable to communicate in English over the telephone, or unable or unwilling to give consent
• Known hypersensitivity to or intolerance of budesonide.

Sponsors & Collaborators

• Mayo Clinic: lead
• AstraZeneca: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colitis, Lymphocytic; Diarrhea

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Colitis, Microscopic; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Study closed early, because of low enrollment. Primary physician for patients with lymphocytic colitis would prescribe Budesonide off label for them. Subjects not interested in placebo trial.

Results Point of Contact

• Title: Dr. Darrell Pardi
• Organization: Mayo Clinic, Rochester MN

pardi.darrell@mayo.edu

507-538-1231

Study Officials

• Darrell S. Pardi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 2, 2021
• Results First Posted: April 12, 2012

Record last verified: 2021-10

Locations

US (1)