SOIBD Collagenous Colitis Maintenance Study

NCT ID: NCT01278082

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

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

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

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

B

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Budesonide

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Budenofalk 3mg capsules

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent,

2. Patients aged >= 18 years,

3. Histologically established diagnosis of collagenous colitis (CC) defined as:

1. Thickened sub-epithelial collagen layer >= 10 µm on well-orientated sections,

2. Increased amount of inflammatory cells indicating chronic inflammation in the lamina propria,

4. 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,

5. A mean of >= 3 stools/day, thereof a mean of >= 1 watery stools/day, during the week prior baseline,

6. 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.

Exclusion Criteria

1. Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps < 2 cm,

2. Infectious cause of diarrhoea,

3. Untreated active celiac disease,

4. Clinical suspicion of drug-induced collagenous colitis,

5. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,

6. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,

7. Local intestinal infection,

8. Radiation therapy towards the abdominal or pelvic region,

9. Diabetes mellitus, infection, glaucoma, tuberculosis, peptic ulcer disease, or hypertension if careful medical monitoring is not ensured,

10. Known established cataract,

11. Known hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, Lapp lactase deficiency, or congenital lactase deficiency,

12. Established osteoporosis with T-score < -2.5,

13. Pregnancy or lactation,

14. History of cancer in the last five years,

15. History of significant bowel resection,

16. Therapy with immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) in the last 3 months,

17. Treatment with oral, rectal, or intravenous corticosteroids including budesonide in the last month,

18. Known intolerance/hypersensitivity to study drug or drugs of similar chemical structure or pharmacological profile,

19. Patients who are unable to adhere to the study visit schedule and other protocol requirements according to the judgement of the investigator,

20. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Organization for Studies on Inflammatory Bowel Disease

OTHER

Sponsor Role: collaborator

Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Müller, Dr

Role: STUDY_DIRECTOR

Dr. Falk Pharma GmbH

Locations

Center of digestive diseases

Hamburg, , Germany

University Hospital of Linköping

Linköping, , Sweden

Countries

Germany; Sweden

References

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.

Reference Type: RESULT

PMID: 25425655 (View on PubMed)

Other Identifiers

2007-001315-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BUC-63/COC

Identifier Type: -

Identifier Source: org_study_id