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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. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2014 |
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Main ID: |
EUCTR2007-003745-32-GB |
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Date of registration:
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26/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAM
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Scientific title:
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A randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAM |
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Date of first enrolment:
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12/12/2008 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003745-32 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Sporadic LAM diagnosed either by cystic lung disease on HRCT classical of LAM plus angiomyolipoma or chylous effusion or cystic lung disease on HRCT and tissue biopsy showing LAM or angiomyolipoma
• TSC-LAM diagnosed by cystic lung disease on HRCT and tuberous sclerosis diagnosed by modified Gomez criteria.
• Patients with either an FEV1 below 80% predicted or evidence of a 20% deterioration in FEV1.
• Hormone and bronchodilator treatment for LAM* is allowed providing treatment has not changed in the three months prior to enrolment.
* progesterone, GnRh agonists and bronchodilators.
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:
• Inability to give informed consent.
• Mental retardation.
• Age less than 18 years.
• Pneumothorax, chylous effusion, bleeding angiomyolipoma or change in hormone treatment within 3 months.
• Previous organ transplantation.
• Severe or uncontrolled epilepsy.
• Use of any oral contraceptive pill.
• Pregnancy or breast feeding. Pre-menopausal patients must be willing to use appropriate birth control measures to avoid pregnancy while enrolled in the study.
• Major systemic diseases (malignancy, myocardial infarction or unstable angina, type1 diabetes, severe hypertension, liver cirrhosis).
• Use of drugs known to interact with doxycycline, including anticoagulation with warfarin.
• Anticoagulation with warfarin.
• Hypersensitivity to tetracyclines.
• Treatment with mTOR inhibitor within the previous 3 months (sirolimus, everolimus).
• Use of doxycycline or other experimental drug within the previous three months.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Lymphangioleiomyomatosis
MedDRA version: 9.1
Level: LLT
Classification code 10049459
Term: Lymphangioleiomyomatosis
MedDRA version: 9.1
Level: PT
Classification code 10049459
Term: Lymphangioleiomyomatosis
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Intervention(s)
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Trade Name: Doxycycline 100 mg Capsules
Pharmaceutical Form: Capsule*
INN or Proposed INN: doxycycline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Mean rate of change of FEV1/year over 24 months on doxycycline compared with placebo.
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Secondary Objective: (1) determine the optimum dose of doxycycline needed to suppress MMP production
(2) define the safety profile of doxycycline in LAM
(3) provide evidence of efficacy and size of effect
(4) determine the optimum design and logistics of future trials.
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Main Objective: Does doxycycline prevent matrix metalloproteinase dependent tissue destruction in lymphangioleiomyomatosis (LAM) thus preserving lung function, exercise capacity and quality of life in LAM?
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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