Fibromyalgia syndrome (FMS).
Conditions
Interventions
Product Name: Ropinirole Controlled Release (CR) Tablets
Product Code: SKF-101468
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: ropinirole
CAS Number: 91374-20-8
Current Sponsor c
Sponsors
GlaxoSmithKline Research & Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Subject is a male or female outpatient, at least 18 years of age. A female is eligible to enter and participate in the study if she is of: a Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or, b Childbearing potential, has a negative result on all required pregnancy tests prior to randomization, and agrees to an acceptable contraceptive method as defined in the protocol. 2. Subject has a diagnosis of fibromyalgia as confirmed by the American College of Rheumatology (ACR) criteria. 3. Subject has baseline PI-NRS score averaging greater than or equal to 4 during the week prior to randomization (Baseline Period) and at least four pain intensity observations are recorded during the 7 days of the Baseline Period. 4. Subject is considered clinically appropriate for therapy with ropinirole based upon the Investigator’s overall clinical evaluation. 5. Subject is in good general health apart from fibromyalgia, as determined by the Investigator (based upon the physical and laboratory examinations, ECG and medical history). 6. Subject is able to comprehend the study procedures and schedule and is able to comply with study requirements. 7. Subject has given informed consent prior to participation in the study. The contents and process of obtaining informed consent will be in accordance with all applicable regulatory requirements. 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
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Other chronic pain condition(s) not associated with FMS. 2. Unable to discontinue prohibited medications administered for the relief of pain of FMS or for depression and known to induce drowsiness for the required washout period and throughout the study. 3. Subject has had non-drug therapies for fibromyalgia (such as herbal or holistic medications) or any other special procedures for fibromyalgia (e.g. TENS, acupuncture) within two weeks prior to the time of randomisation or will not be able to forgo these therapies/procedures during the study. Stable exercise regimens may be continued if subjects have been on them for at least 2 weeks prior to the randomisation. 4. Known history of hypersensitivity or intolerance to acetaminophen/paracetamol. 5. Withdrawal, introduction, or change in dose of HRT and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, Hormone Replacement Therapy) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. 6. Taking any medication with the potential for pharmacokinetic interaction with ropinirole. 7. Prior exposure to ropinirole during a previous clinical trial for any indication. 8. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than FMS), or cardiovascular disease or active malignancy (other than basal cell cancer) 9. Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG. 10. Subject has any clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG, which in the opinion of the investigator, could interfere with the interpretation of efficacy or safety data, or which otherwise would contraindicate participation in a clinical study. 11. ECG or clinical evidence of atrial or ventricular hypertrophy; intraventricular conduction defects (excluding incomplete right bundle branch block in the absence of clinical evidence of heart disease); symptomatic coronary artery disease (or any symptomatic cardiac disease); myocardial strain, ischaemia, or infarct; atrial arrhythmia (must be in normal sinus rhythm); second- or third-degree AV block; congestive heart failure; cor pulmonale; or any cardiac condition that the investigator feels may predispose the subject to ischaemia or arrhythmia Subject has symptoms of a major depressive episode or active significant psychiatric disorders. Subjects with a history of depression that has required ongoing, current treatment with antidepressants are excluded. 12. History of clinically significant drug or alcohol abuse as defined by DSM-IV or is unable to refrain from substance abuse throughout the study. 13. Use of any investigational drug within 4 weeks (or 5 half-lives, whichever is longer) prior to the Screening Visit or is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device. 14. History of hypersensitivity or intolerance to ropinirole or associated excipients or dopamine. 15. Pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of oral ropinirole controlled release formulation (CR) compared to placebo over a dose range in adult subjects with FMS as measured by the 11-point Pain Intensity Numerical Rating Scale (PI-NRS);Secondary Objective: 1.To evaluate the safety and tolerability of ropinirole (CR) over a dose range in subjects with FMS 2.To further evaluate the efficacy of ropinirole (CR) over a dose range in terms of: - Pain intensity - Proportion of responders - Patient and Clinician Global Impression of Change - Pain relief - Pain severity and its impact on daily functioning - Tender point assessment - Fibromyalgia Impact Questionnaire - Sleep quality - Rescue medication - Time to onset of analgesic effect 3. To evaluate the effect of ropinirole (CR) on health-related quality of life outcomes, including physical and emotional functioning. 4. To describe the pharmacokinetics of ropinirole in subjects with FMS following oral administration of ropinirole CR. 5. To explore any relationship between systemic exposure to ropinirole and clinical outcome in subjects with FMS. ;Primary end point(s): Change in pain intensity score from baseline (average of the Baseline Phase pain intensity scores) to the last week of treatment (Week 12), measured by the 11 point Pain Intensity Numerical Rating Scale (PI-NRS). | — |
Countries
Denmark, Finland, Germany, Italy, Sweden, United Kingdom
Outcome results
None listed