|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
30 June 2019 |
|
Main ID: |
EUCTR2007-006658-24-GB |
|
Date of registration:
|
22/10/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day)
for initial treatment of bullous pemphigoid
- Bullous Pemphigoid Steroids & Tetracyclines Study
|
|
Scientific title:
|
A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day)
for initial treatment of bullous pemphigoid
- Bullous Pemphigoid Steroids & Tetracyclines Study |
|
Date of first enrolment:
|
05/03/2009 |
|
Target sample size:
|
256 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006658-24 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Investigator is blinded to treatment allocation for the first 6 weeks only
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
Germany
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
• Aged at least eighteen years old.
• Able to provide written informed consent.
• Diagnosed with bullous pemphigoid defined as:
o Clinical features consistent with bullous pemphigoid.
• To be eligible for the study, the patient will need to have either a positive direct or indirect immuno- fluorescence.
o Direct or indirect (serum) immuno-fluorescence (linear IgG/C3 at epidermal basement membrane zone) positive for bullous pemphigoid.
• At least three significant blisters at two or more body sites that have appeared in the week prior to study enrolment. Significant blisters are defined as intact blisters containing fluid which are at least 5mm in diameter. However, if the patient has popped a blister, or the blister is at a site that makes it susceptible to bursting such as the sole of the foot, it can be considered part of the blister count, providing there is a flexible (but not dry) roof present over a moist base.
• Free of blisters and any treatment for bullous pemphigoid for at least one year.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Received any of the study medications or other recognised systemic medications for the treatment of this episode of bullous pemphigoid prior to study entry. Prior topical treatment is permitted.
• Recent administration of a live virus vaccine.
• Mainly or entirely mucosal bullous pemphigoid.
• Known allergy to tetracyclines.
• Presence of any condition which precludes the use of either of the study drugs.
• Women who are taking the oral contraceptive pill, who are pregnant or plan to become pregnant during the study duration or lactating. Women of childbearing potential must be using adequate contraception and be prepared to avoid pregnancy while participating in the study.
• Cancer (apart from basal cell carcinoma).
• Has any other condition which would, in the Investigators opinion, deem the patient unsuitable for participation in the study.
• Taking part in any other intervention study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
BP is a serious condition with a significant associated morbidity and mortality rate. Widespread tense and haemorrhagic blisters, skin erosions and severe itching cause patients a great deal of distress and pain. It occurs mainly in the elderly. The mortality rate in treated patients is estimated to range from 20% - 40% at one year.
MedDRA version: 14.0
Level: LLT
Classification code 10006568
Term: Bullous pemphigoid NOS
System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.0
Level: LLT
Classification code 10006567
Term: Bullous pemphigoid
System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
|
|
Intervention(s)
|
Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
CAS Number: 50-24-8
Product Name: doxycycline
Pharmaceutical Form: Capsule
INN or Proposed INN: doxycycline
CAS Number: 50-24-8
Product Name: prednisolone
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: prednisolone
CAS Number: 50-24-8
Product Name: prednisolone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: prednisolone
CAS Number: 50-24-8
Product Name: doxycycline
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: doxycycline
CAS Number: 50-24-8
|
|
Primary Outcome(s)
|
Main Objective: • To assess whether doxycycline can be considered as non-inferior to prednisolone in effectiveness for the treatment of bullous pemphigoid given an accepted non-inferiority margin.
• To assess the safety of doxycycline compared with the prednisolone for the treatment of bullous pemphigoid.
|
|
Secondary Objective: • To assess the cost-effectiveness of the two treatments.
|
Primary end point(s): • Difference between the two treatment arms in the proportion of participants classed as treatment success at 6 weeks. Treatment success is defined as 5 or less significant blisters present on examination at 6 weeks. Significant blisters are defined as intact blisters containing fluid which are at least 5mm in diameter. However, if the patient has popped a blister, or the blister is at a site that makes it susceptible to bursting such as the sole of the foot, it can be considered part of the blister count, providing there is a flexible (but not dry) roof present over a moist base.
• Difference between the two treatment arms in the number of reported grade 3, 4 and 5 (mortality) adverse events for one year following the start of study treatment. The Common Terminology Criteria for Adverse Events (CTCAE v3.0) will be used to grade adverse events. At each study visit, participants will be questioned about adverse events they have experienced since the last study visit (using a standard list of known side effects of the two study drugs).
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|