SOIBD Collagenous Colitis Maintenance Study (SCCMS)

This study has been completed.
Sponsor:
Collaborator:
The Swedish Organization for Studies on Inflammatory Bowel Disease
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01278082
First received: January 14, 2011
Last updated: November 14, 2013
Last verified: November 2013

January 14, 2011
November 14, 2013
April 2008
March 2013   (final data collection date for primary outcome measure)
Proportion of patients being in remission over 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
Same as current
Complete list of historical versions of study NCT01278082 on ClinicalTrials.gov Archive Site
  • Proportion of patients in remission at wk 4, 13, 26, and 39. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day
  • Adverse events (AEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
SOIBD Collagenous Colitis Maintenance Study
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Induction and Maintaining Remission of Collagenous Colitis
  • 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 Name: Budenofalk 3mg capsules
  • Drug: Placebo
    Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
  • Experimental: A
    Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
    Intervention: Drug: Budesonide
  • Placebo Comparator: B
    Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
September 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden
 
NCT01278082
BUC-63/COC, 2007-001315-31
Yes
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
The Swedish Organization for Studies on Inflammatory Bowel Disease
Study Director: Ralph Müller, Dr Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP