A randomized, double-blind, placebo-controlled, multicenter evaluation of the efficacy and safety of terguride tablets, administered orally for 3 months, to patients with fibromyalgia.
- Conditions
- fibromyalgiaMedDRA version: 8.1Level: LLTClassification code 10048439Term: Fibromyalgia
- Registration Number
- EUCTR2006-002477-45-CZ
- Lead Sponsor
- ErgoNex Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
Patients (m or f) are eligible for the study when they fulfil the following criteria:
·Diagnosis of fibromyalgia according to ACR criteria (1990) [Wolfe et al. 1990]
·Pain score ³50 mm on the patient pain VAS (100 mm)
·Tender point Score (TPS) ³ 11
·Age range from 18 to 60 y (inclusive)
·Body Mass Index (BMI): 18.9 < BMI < 30.0
·A written informed consent to participate in this study signed by the subject prior to initiation of any study specific procedure
·Treatment as outpatients
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
A patient fulfilling the following exclusion criteria must not enter the study:
·known sensitivity to study drug
·suffering from relevant liver (limit for GOT and GPT: < 3-fold of upper limit of NR), kidney (limit for serum creatinine: < 1.5 mg/dL), cardiovascular (i.e. heart attack or cerebrovascular disease) or pulmonary disease (i.e. asthma or COPD)
·suffering from pituitary tumor representing extrasellar expansion
·suffering from peptic ulcers or having a history of it
·suffering from Raynaud syndrome or having a history of it
·suffering from psychosis or having a history of it
·suffering from a systolic blood pressure ³140 mm Hg and a diastolic pressure ³ 90 mm Hg. (Criteria in accordance with the 7th report of the joint national committee on prevention, detection, evaluation and treatment of high blood pressure (NIH Publication # 04-5230 (2004))
·suffering from Encephalomyelitis disseminata
·suffering from chronic inflammatory diseases
·evidence or history of drug or alcohol abuse
·mental impairment limiting the ability to comply with study requirements
·receiving therapy with agents known or likely to interact with study drug or disease:
- Antidepressants or SSRIs are not allowed from 6 weeks before V(-1) throughout the entire study. However, patients with substantial therapeutic benefit from such compounds should not be discontinued for study participation.
- Antiepileptics, Anxiolytics, Muscle relaxants or Hypnotics have to be discontinued at least 10 elimination half lives of the respective drug before V(-1); for details see section 9.4.7,
·participation in any clinical study or donation of blood in the period from 60 days prior to study initiation until end of study .
Additionally, women with child bearing potential must be excluded if:
·They have not used reliable contraception in the cycle before the study. According to CPMP/ICH/286/95 (modification) highly effective methods of birth control (defined by a failure rate < 1% per year) include the consistent and correct use of implants, injectables combined oral contraceptives, selected intrauterine devices (IUD), sexual abstinence or vasectomised partner The subject has to agree to continue using such highly reliable contraception during the entire study period and the cycle after the study
·They are pregnant or lactating. (A negative pregnancy test must be provided for all female subjects with child bearing potential at screening and on Day 0)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority of terguride 3 mg/d over placebo in the 12 week treatment of fibromyalgia associated pain on the visual analogue scale (VAS) called Schmerzskala from Mundipharma.;Secondary Objective: To investigate the safety and tolerability of terguride in patients suffering from fibromyalgia.<br>To assess the influence of terguride on: <br>·Fibromyalgia Impact Questionnaire (FIQ-G), <br>·Tender Point Score (TPS),<br>·Hamilton Depression Scale<br>;Primary end point(s): The primary efficacy variable is the pain intensity given by the patient on the VAS (0 100 mm) called Schmerzskala from Mundipharma. The absolute and relative (%) change from baseline (V0) to V12 will be calculated for each patient.
- Secondary Outcome Measures
Name Time Method