Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2022-06-30
2023-11-30
Brief Summary
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Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.
The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Milnacipran
Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months
Milnacipran
Milnacipran will be administered according to the treatment recommendations for fibromyalgia, starting with 50 mg once daily for 1 week then increasing to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 months.
Gabapentin
patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months
Gabapentin
Patients will receive gabapentin (1200 mg twice daily) as a monotherapy. Gabapentin will be administered according to the treatment recommendations for FM patients starting with 400 mg 3 times per day, then increasing the dose to 800 mg 3 times per day with a maximum dose of 2400 mg per day according to efficacy and tolerability for 3 months
Combined gabapentin/milnacipran
Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months
Combined gabapentin/milnacipran
Patients will receive combined gabapentin as group B and MLN as group A
Interventions
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Milnacipran
Milnacipran will be administered according to the treatment recommendations for fibromyalgia, starting with 50 mg once daily for 1 week then increasing to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 months.
Gabapentin
Patients will receive gabapentin (1200 mg twice daily) as a monotherapy. Gabapentin will be administered according to the treatment recommendations for FM patients starting with 400 mg 3 times per day, then increasing the dose to 800 mg 3 times per day with a maximum dose of 2400 mg per day according to efficacy and tolerability for 3 months
Combined gabapentin/milnacipran
Patients will receive combined gabapentin as group B and MLN as group A
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or breastfeeding.
* Active liver disease
* Renal impairment (creatinine clearance \< 60 mL/min).
* Documented autoimmune disease.
* Severe chronic obstructive pulmonary disease.
* Recent arrhythmia
* Myocardial infarction
* Stroke.
* Uncontrolled hypertension.
* Glaucoma.
18 Years
70 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Amr M Yassin, MD
Role: STUDY_CHAIR
Professor of Anesthesia and Surgical Intensive Care
Eiad A Ramzy, md
Role: STUDY_DIRECTOR
Assistant Professor of Anesthesia and Surgical Intensive Care
Locations
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Mansoura University
Al Mansurah, DK, Egypt
Countries
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Other Identifiers
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MFM-IRBŲ MD.21.12.577
Identifier Type: -
Identifier Source: org_study_id
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