SOIBD Collagenous Colitis Maintenance Study

NCT01278082 | Completed Phase 3 DMC

• 2 other identifiers: BUC-63/COC2007-001315-31
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 2

Brief Summary

This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period

Conditions

Induction and Maintaining Remission of Collagenous Colitis

Keywords

Randomized; double-blind; Placebo-controlled; budesonide; collagenous colitis; acute treatment; maintaining remission

Outcome Measures

Primary Outcomes (1)

• Proportion of patients being in remission over 52 weeks.

  Remission is defined as a mean of \< 3 stools/day, thereof a mean of \< 1 watery stools/day

  52 weeks

Secondary Outcomes (2)

• Proportion of patients in remission at wk 4, 13, 26, and 39.

  39 weeks

• Adverse events (AEs)

  52 weeks

Study Arms (2)

A

EXPERIMENTAL

Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day

Drug: Budesonide

B

PLACEBO COMPARATOR

Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.

Drug: Placebo

Interventions

Budesonide DRUG

Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day

Also known as: Budenofalk 3mg capsules

A

Placebo DRUG

Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.

B

Eligibility Criteria

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

You may qualify if:

• Signed informed consent,
• Patients aged \>= 18 years,
• Histologically established diagnosis of collagenous colitis (CC) defined as:
• Thickened sub-epithelial collagen layer \>= 10 µm on well-orientated sections,
• Increased amount of inflammatory cells indicating chronic inflammation in the lamina propria,
• History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in patients with newly diagnosed collagenous colitis, or history of clinical relapse for more than 1 week prior screening in patients with previously established collagenous colitis,
• A mean of \>= 3 stools/day, thereof a mean of \>= 1 watery stools/day, during the week prior baseline,
• Women of child-bearing potential and being heterosexually active have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

You may not qualify if:

• Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps \< 2 cm,
• Infectious cause of diarrhoea,
• Untreated active celiac disease,
• Clinical suspicion of drug-induced collagenous colitis,
• Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
• Abnormal hepatic function (ALT or ALP \> 2.5 x upper limit of normal \[ULN\]), liver cirrhosis, or portal hypertension,
• Local intestinal infection,
• Radiation therapy towards the abdominal or pelvic region,
• Diabetes mellitus, infection, glaucoma, tuberculosis, peptic ulcer disease, or hypertension if careful medical monitoring is not ensured,
• Known established cataract,
• Known hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, Lapp lactase deficiency, or congenital lactase deficiency,
• Established osteoporosis with T-score \< -2.5,
• Pregnancy or lactation,
• History of cancer in the last five years,
• History of significant bowel resection,

Sponsors & Collaborators

• Dr. Falk Pharma GmbH: lead
• The Swedish Organization for Studies on Inflammatory Bowel Disease: collaborator

Study Sites (2)

Center of digestive diseases

Hamburg, 20249, Germany

Location

University Hospital of Linköping

Linköping, 58185, Sweden

Location

Related Publications (1)

• Munch A, Bohr J, Miehlke S, Benoni C, Olesen M, Ost A, Strandberg L, Hellstrom PM, Hertervig E, Armerding P, Stehlik J, Lindberg G, Bjork J, Lapidus A, Lofberg R, Bonderup O, Avnstrom S, Rossle M, Dilger K, Mueller R, Greinwald R, Tysk C, Strom M; BUC-63 investigators. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial. Gut. 2016 Jan;65(1):47-56. doi: 10.1136/gutjnl-2014-308363. Epub 2014 Nov 25.

  PMID: 25425655 RESULT

MeSH Terms

Conditions

Colitis, Collagenous

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Colitis, Microscopic; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ralph Müller, Dr

  Dr. Falk Pharma GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: April 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

DE (1); SE (1)