Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

• Conditions: Acute mild to moderate ulcerative colitis.; MedDRA version: 14.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002462-20-SK
• Lead Sponsor: Dr August Wolff GmbH & Co KG Arzneimittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-27
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Provide written informed consent, i.e. they must be willing and able to comply with the study procedures.
2. Adult males or females, aged 18 to 70 years (inclusive).
3. Females of childbearing potential must have a negative urine pregnancy test at screening and must agree to use adequate contraception (e.g. oral, depot or implanted hormonal contraception, intrauterine device, surgical sterilisation or partner vasectomy) from screening visit until at least 4 weeks after last dose of study medication (Week 12).
4. Females of non-child bearing potential should be postmenopausal for >1 year or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
5. Male patients must agree to use adequate contraception (e.g. vasectomy or adequate partner contraception).
6. Body mass index (BMI) =19 and =30 kg/m2.
7. Mild to moderately active UC proven by endoscopy and criteria according to European Crohn's and Colitis Organisation (ECCO) guidelines and defined as a CAI of 6 to 12.
8. Pre-treatment of active ulcerative colitis with one of the following:
- a stable dose of oral mesalazine, sulphasalazine or olsalazine for >4 weeks (oral), and/or
- a stable dose of azathioprine or 6-mercaptopurin for >3 months, or
- a stable dose of oral corticosteroids of =20 mg oral prednisolone or equivalent for >2 weeks before baseline.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
;
1. Provide written informed consent, i.e. they must be willing and able to comply with the study procedures.
2. Adult males or females, aged 18 to 70 years (inclusive).
3. Females of childbearing potential must have a negative urine pregnancy test at screening and must agree to use adequate contraception (e.g. oral, depot or implanted hormonal contraception, intrauterine device, surgical sterilisation or partner vasectomy) from screening visit until at least 4 weeks after last dose of study medication (Week 12).
4. Females of non-child bearing potential should be postmenopausal for >1 year or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
5. Male patients must agree to use adequate contraception (e.g. vasectomy or adequate partner contraception).
6. Body mass index (BMI) =19 and =30 kg/m2.
7. Mild to moderately active UC proven by endoscopy and criteria according to European Crohn's and Colitis Organisation (ECCO) guidelines and defined as a CAI of 6 to 12.
8. Pre-treatment of active ulcerative colitis with one of the following:
- a stable dose of oral mesalazine, sulphasalazine or olsalazine for >4 weeks (oral), and/or
- a stable dose of azathioprine or 6-mercaptopurin for >3 months, or
- a stable dose of oral corticosteroids of =20 mg oral prednisolone or equivalent for >2 weeks before baseline.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Pregnant, planning to become pregnant during the study, or breast feeding females.
2. Previous participation in any clinical study with K(D)PT.
3. Crohn’s disease.
4. Treatment-naive.
5. Infectious diarrhoea within 14 days before or during the treatment period.
6. Indeterminate colitis.
7. Significantly impaired liver, renal, pulmonary or cardiovascular function.
8. Use of antibiotics within 4 weeks before or during the treatment period.
9.Use of E. coli Nissle within 4 weeks before or during the treatment period.
10. Previous use of cyclosporine, anti-TNF therapy (e.g. infliximab) or tacrolimus at any time.
11. Any rectal therapy four weeks before or during the treatment period.
12. Use of corticosteroids >20 mg oral prednisolone or equivalent.
13. Use of methotrexate within 3 months before or during the treatment period.
14. Use of anti-diarrhoeal drugs within 2 weeks before or during the treatment period.
15. Effective anti-coagulation therapy (e.g. Marcumar) or severe grade coagulation defects.
16. Any clinically relevant abnormal findings at screening, vital signs or ECG which, in the opinion of the investigator, may put the patient at risk because of his or her participation in the study.
17. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or could influence the results, or the patient’s ability to participate in the study.
18. History of or current alcohol or drug abuse, as judged by the investigator.
19. Participation in another investigational drug study within 3 months before first administration of study medication.
20. Donation of blood within 3 months, or donation of plasma within 2 weeks, before the first administration of study medication.
21. Proctitis (=5 cm).
22. QTcF >450 ms or <350 ms or QT >500 ms or other relevant ECG abnormality as judged by the investigator.
23. History of pathological skin condition.
24. Known intolerance to methylparaben or propylparaben.
25. Known intolerance to any other excipient of the investigational medicinal product (IMP).
26. Positive history of hepatitis B and/or C and/or history of human immunodeficiency virus (HIV).
27. Planned surgery or hospitalisation during the study.
28. Patients who, in the opinion of the investigator, should not participate in the study.
29. Patients unable to understand informed consent.
;
1. Pregnant, planning to become pregnant during the study, or breast feeding females.
2. Previous participation in any clinical study with K(D)PT.
3. Crohn’s disease.
4. Treatment-naive.
5. Infectious diarrhoea within 14 days before or during the treatment period.
6. Indeterminate colitis.
7. Significantly impaired liver, renal, pulmonary or cardiovascular function.
8. Use of antibiotics within 4 weeks before or during the treatment period.
9.Use of E. coli Nissle within 4 weeks before or during the treatment period.
10. Previous use of cyclosporine, anti-TNF therapy (e.g. infliximab) or tacrolimus at any time.
11. Any rectal therapy four weeks before or during the treatment period.
12. Use of corticosteroids >20 mg oral prednisolone or equivalent.
13. Use of methotrexate within 3 months before or during the treatment period.
14. Use of anti-diarrhoeal drugs within 2 weeks before or during the treatment period.
15. Effective anti-coagulation therapy (e.g. Marcumar) or severe grade coagulation defects.
16. Any clinically relevant abnormal findings at screening, vital signs or ECG which, in the opinion of the investigator, may put the patient at risk because of his or her participation in the study.
17. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or could influence the results, or the patient’s ability to participate in the study.
18. History of or current alcohol or drug abuse, as judged by the investigator.
19. Participation in another investigational drug study within 3 months before first administration of study medication.
20. Donation of blood within 3 months, or donation of plasma within 2 weeks, before the first administration of study medication.
21. Proctitis (=5 cm).
22. QTcF >450 ms or <350 ms or QT >500 ms or other relevant ECG abnormality as judged by the investigator.
23. History of pathological skin condition.
24. Known intolerance to methylparaben or propylparaben.
25. Known intolerance to any other excipient of the investigational medicinal product (IMP).
26. Positive history of hepatitis B and/or C and/or history of human immunodeficiency virus (HIV).
27. Planned surgery or hospitalisation during the study.
28. Patients who, in the opinion of the investigator, should not participate in the study.
29. Patients unable to understand informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified