EUCTR2006-006100-11-GBActive, not recruitingPhase 1
A multicenter, multiple dose, double-blind, randomized, placebo-controlled, parallel group study of the safety and efficacy of AGN 203818 in female patients with fibromyalgia syndrome.
Allergan Ltd0 sites160 target enrollmentStarted: March 28, 2007Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •- Written informed consent and data protection consent has been obtained.
- •- Female patients 18 to 75.
- •- Patient has fibromyalgia syndrome (FMS) as defined by the American College of Rheumatatology (1990) criteria.
- •- FMS is the patient's primary painful condition.
- •- Patient has pain associated with FMS defined according to the 11 point Likert scale.
- •- WOCBP must have a negative pregnancy test at screening.
- •- Patient is acceptable for enrollment as determined by the investigator from the screening procedures.
- •- Patient must be able to understand and co-operate with the study requirements and instructions and be willing and able to complete all study visits.
- •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
- •- Anticipated change or recent initiation of pharmacological or non-pharmacological therapies for FMS.
- •- Use of any prohibited medications prior to baseline visit.
- •- Patient using herbal supplements and not on a stable and regular dose for at least 4 weeks prior to baseline.
- •- Uncontrolled concurrent disease other than FMS.
- •- Positive test for hepatitis B, hepatitis C or HIV virus antibodies at screening.
- •- Thyroid function test results that are considered unacceptable.
- •- Thyroidectomy or radio-iodine therapy for hyperthyroidism with 12 months of baseline.
- •- History of rheumatoid arthritis, inflammatory arthritis, autoimmune disease associated with pain or other significant painful conditions that may confound the study.
- •- Previous or current diagnosis of manic or hypomanic episode (bipolar disorder) or psychotic disorder, including current or lifetime diagnosis of these diagnostic categories identified by the Mini- International Neuropsychiatric Interview (MINI)
- •- Current diagnosis of a major depressive episode, dysthymic disorder, or generalised anxiety disorder irrespective of whether the disorder is currently controlled by pharmacological treatment, including any of the above listed diagnostic categories or a moderate or high suicidal risk, identified by the MINI, or at risk of self-harm.
- •- Score greater than or equal to 2 on question 9 (suicide) of the Beck Depression Inventory at baseline, or at risk of self-harm.
- •- Clinically significant hypotension (including symptomatic orthostatic).
- •- History of significant allergic condition including severe drug-related hypersensitivity (e.g. anaphylactic reaction)
- •- Known allergy or sensitivity to any compound or chemical class related to AGN 203818 or its excipients.
- •- Previously participated in an AGN 203818 study.
- •- History of treatment for or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of 2 units per day.
- •- Current enrollment in another IP or device study.
- •- WOCP who is not using a double-barrier method of contraception.
- •- Pregnancy, nursing, or planning a pregnancy.
- •- Anticipated need for surgery or hospitalisation during the study.
- •- Currently applying for disability allowance or have ongoing litigation activities related to their medical condition.
- •- A condition or situation which may put the patient at significant risk, may confound the study results or interfere significantly with participation.
Investigators
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