A PHASE II DOUBLE BLIND MODIFIED CROSS OVER DESIGN STUDY EVALUATING THE EFFICACY AND SAFETY OF TRIMETAZIDINE (GENERICS UK LIMITED) AND PLACEBO IN THE TREATMENT OF FIBROMYALGIA
- Conditions
- FibromyalgiaMedDRA version: 9.1Level: LLTClassification code 10048439Term: Fibromyalgia
- Registration Number
- EUCTR2007-001743-21-DE
- Lead Sponsor
- Generics (UK) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects fulfilling the following criteria are eligible for participation in the study:
(1)Male or female
(2)Age equal or more than18 years
(3)Body weight between 60 and 130 kg for males and 50 and 110 kg for females. In addition the BMI range limit of 18 – 32 kg/m2 (both inclusive) is applicable .
(4)Diagnosed by an expert as having primary fibromyalgia.
(5)Newly diagnosed subjects or uncontrolled subjects currently experiencing pain (score > 5 < 8 on the VAS)
(6)No significant concurrent illness apart from fibromyalgia
(7)Available for the entire study period and are willing to adhere to the protocol requirements.
(8)Have signed consent form after the nature of the study has been fully explained.
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) no
F.1.3.1 Number of subjects for this age range
Subjects who meet one of more of the following criteria are not eligible:
(1)History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
(2)History of autoimmune disease or inflammatory arthropathy (e.g. rheumatoid arthritis, systemic lupus erythematosus) as evidenced either clinically or by serology (elevated rheumatoid factor, antinuclear antibody etc.)
(3)Clinical and laboratory evidence or history of hepatitis B or C (antibodies)
(4)Subject is HIV-seropositive
(5)Change in medication within the last 4 weeks prior to the first administration of the test product and throughout the study
(6)History of major psychiatric disease.
(7)Subjects with any other disease, which in the opinion of the investigator is likely to affect the results of the study or subject safety.
(8)Subjects with screening laboratory test values greater than 2.5 times the normal value.
(9)Recent history (<1 year) or presence of alcohol abuse or substance abuse. A bit extreme ..no alcohol for a year prior to study?
(10)History of blood loss exceeding 450 ml (including blood donations) within 1 month before the study.
(11)Use of any other experimental drug within the previous 3 months prior to first dose and throughout the study.
(12)Not willing or able to provide written informed consent for participation in the study after being informed by the investigator about the aim, course and possible risks of the study.
(13)Not willing to give consent for transmission of personal pseudonymised data
(14)Not willing and able to use a contraceptive method, which the investigator considers reliable. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence. Women must use reliable methods from 6 weeks before the first administration of test product until 3 weeks after the last administration of the study medication. Men and their female partners must use reliable methods from the first administration of test product until 3 weeks after the final examination. Methods for men are condoms, sexual abstinence and sterilization.
(15)For females: pregnancy or lactation
(16)Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to demonstrate the efficacy of trimetazidine in subjects with fibromyalgia by testing the hypothesis that the test product trimetazidine is superior to placebo in reducing pain, as determined by the change from baseline of the pain visual analogue score after 10 days treatment.;Secondary Objective: The secondary objective of this study is to further explore efficacy and safety of trimetazidine as compared to placebo in subjects with fibromyalgia.;Primary end point(s): Change from baseline on the pain visual analogue score of the mean pain measured over the last 3 days of the treatment period.
- Secondary Outcome Measures
Name Time Method