- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905486
Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.
The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects: The study will include 50 patients diagnosed as having fibromyalgia according to the ACR 2010 Fibromyalgia diagnostic criteria.
Methods: Patients will be classified into two groups:
1) Group 1: Patients will receive pregabalin as a monotherapy and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week based on efficacy and tolerability.
7) Group 2: Patients will receive combined pregabalin and milnacipran and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week for the pregabalin and starting by 12.5 mg increasing gradually to reach 100 mg daily of milnacipran based on efficacy and tolerability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt, 00123
- Alexandria University, Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female patients
- diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria
Exclusion Criteria:
- Patients with major medical disorders or uncontrolled medical conditions
- Patients with recent myocardial infarction or stroke,
- Patients with active liver disease,
- Patients with renal impairment (creatinine clearance < 60 ml/min),
- Patients with documented autoimmune disease,
- Patients with severe chronic obstructive pulmonary disease,
- Patients with unstable diabetes,
- pregnancy or breastfeeding patients
- Patients with exposed to any investigational drug within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: G1: patients will receive pregabalin
pregabalin as a mono-therapy will be administered in increment doses for 3 months
|
Group 1: will receive pregabalin as a monotherapy.
Pregabalin will be administered according to the treatment recommendations for fibromyalgia in the package insert [Pfizer Inc., 2012] starting by 50 mg twice daily increasing to 300 mg twice daily according to the efficacy and tolerability for 3 months.
|
Active Comparator: G2: patients will receive pregabalin and milnacipran
pregabalin and milancipran as a combination therapy will be administered in increment doses for 3 months
|
Group 2: will receive a combined pregabalin and milancipran.
Pregabalin will be administered as group 1, while milancipran will be administered according to the treatment recommendations for fibromyalgia, starting by 50 mg once daily for 1 week then increased to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fibromyalgia impact questionnaire (FIQ)
Time Frame: 3 months
|
assesses the overall functional ability and the impact of fibromyalgia on the patients life, with a range from 0-100, 0 indicating no functional impairment or effect of the disease on the patients life and 100 indicating a very bad and tremendous effect of fibromyalgia on the patients life
|
3 months
|
visual analogue scale (VAS) for pain
Time Frame: 3 months
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assesses the overall pain of fibromyalgia on a 100 mm pain scale with 0 indicating no pain and 100 indicating the worst pain ever
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leeds sleep evaluation questionnaire
Time Frame: 3 months
|
The four aspects of sleep around which the questionnaire is devised (Getting to sleep, GTS; Quality of sleep, QOS; Awakening from sleep, AFS; Behaviour following wakefulness, BFW), and assessing the effect of medication on the quality of sleep each question is a 100 mm line that the patient marks, 0 meaning very bad effect or worsening in sleep pattern, 50 meaning no improvement what so ever with no deterioration and 100 meaning excellent improvement in the sleep pattern
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yousra H Abdel-Fattah, Alexandria University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- 0303417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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