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
  Purpose

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


Condition Intervention Phase
Induction and Maintaining Remission of Collagenous Colitis
Drug: Budesonide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: April 2008
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278082

Locations
Germany
Center of digestive diseases
Hamburg, Germany, 20249
Sweden
University Hospital of Linköping
Linköping, Sweden, 58185
Sponsors and Collaborators
Dr. Falk Pharma GmbH
The Swedish Organization for Studies on Inflammatory Bowel Disease
Investigators
Study Director: Ralph Müller, Dr Dr. Falk Pharma GmbH
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01278082     History of Changes
Other Study ID Numbers: BUC-63/COC, 2007-001315-31
Study First Received: January 14, 2011
Last Updated: November 14, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Dr. Falk Pharma GmbH:
Randomized
double-blind
Placebo-controlled
budesonide
collagenous colitis
acute treatment
maintaining remission

Additional relevant MeSH terms:
Colitis
Colitis, Collagenous
Colitis, Microscopic
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014