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SOIBD Collagenous Colitis Maintenance Study (SCCMS)

Primary Purpose

Induction and Maintaining Remission of Collagenous Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide
Placebo
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction and Maintaining Remission of Collagenous Colitis focused on measuring Randomized, double-blind, Placebo-controlled, budesonide, collagenous colitis, acute treatment, maintaining remission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center of digestive diseases
  • University Hospital of Linköping

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2011
Last Updated
January 20, 2016
Sponsor
Dr. Falk Pharma GmbH
Collaborators
The Swedish Organization for Studies on Inflammatory Bowel Disease
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1. Study Identification

Unique Protocol Identification Number
NCT01278082
Brief Title
SOIBD Collagenous Colitis Maintenance Study
Acronym
SCCMS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
Collaborators
The Swedish Organization for Studies on Inflammatory Bowel Disease

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction and Maintaining Remission of Collagenous Colitis
Keywords
Randomized, double-blind, Placebo-controlled, budesonide, collagenous colitis, acute treatment, maintaining remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Budenofalk 3mg capsules
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
Primary Outcome Measure Information:
Title
Proportion of patients being in remission over 52 weeks.
Description
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients in remission at wk 4, 13, 26, and 39.
Description
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
Time Frame
39 weeks
Title
Adverse events (AEs)
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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, Therapy with immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) in the last 3 months, Treatment with oral, rectal, or intravenous corticosteroids including budesonide in the last month, Known intolerance/hypersensitivity to study drug or drugs of similar chemical structure or pharmacological profile, Patients who are unable to adhere to the study visit schedule and other protocol requirements according to the judgement of the investigator, Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Müller, Dr
Organizational Affiliation
Dr. Falk Pharma GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Center of digestive diseases
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
University Hospital of Linköping
City
Linköping
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25425655
Citation
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.
Results Reference
result

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SOIBD Collagenous Colitis Maintenance Study

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