Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.
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|ClinicalTrials.gov Identifier: NCT03905486|
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia, Primary||Drug: Pregabalin 300mg Drug: Combined pregabalin 300mg and milancipran 100mg||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: G1: patients will receive pregabalin
pregabalin as a mono-therapy will be administered in increment doses for 3 months
Drug: Pregabalin 300mg
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
Drug: Combined pregabalin 300mg and milancipran 100mg
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.
- 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
- visual analogue scale (VAS) for pain [ Time Frame: 3 months ]assesses the overall pain of fibromyalgia on a 100 mm pain scale with 0 indicating no pain and 100 indicating the worst pain ever
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905486
|Contact: Yousra Hisham H Abdel-Fattahfirstname.lastname@example.org|
|Contact: Rehab A Elnemremail@example.com|
|Alexandria University, Faculty of Medicine||Recruiting|
|Alexandria, Egypt, 00123|
|Contact: Yousra H Abdel-Fattah 127320303 firstname.lastname@example.org|
|Principal Investigator:||Yousra H Abdel-Fattah||Alexandria University Faculty of Medicine|