SOIBD Collagenous Colitis Maintenance Study (SCCMS)

January 20, 2016 updated by: Dr. Falk Pharma GmbH

Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20249
        • Center of digestive diseases
  • Sweden
      • Linköping, Sweden, 58185
        • University Hospital of Linkoping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
Drug: Budesonide
Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
Other Names:
  • Budenofalk 3mg capsules
Placebo Comparator: B
Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
Drug: Placebo
Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients being in remission over 52 weeks.
Time Frame: 52 weeks
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in remission at wk 4, 13, 26, and 39.
Time Frame: 39 weeks
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
39 weeks
Adverse events (AEs)
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Collaborators

The Swedish Organization for Studies on Inflammatory Bowel Disease

Investigators

  • Study Director: Ralph Müller, Dr, Dr. Falk Pharma GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUC-63/COC
  • 2007-001315-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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