Study comparing the effects and side effects of milnacipran and pregabalin in patients with chronic pain condition known as fibromyalgia

Not Applicable

Recruiting

• Conditions: Fibromyalgia, Patients diagnosed with fibromyalgia using modified ACR 2010 criteria,

• Registration Number: CTRI/2017/03/008113
• Lead Sponsor: Nirmal George

Brief Summary

Subjects diagnosed as having fibromyalgia by the neurologist will be enrolled after explaining the study details to the patients and obtaining written informed consent and will be randomized to open label milnacipran or pregabalin according to computer generated block randomization. Dose titration and attainment of a stable dose will be done in 1 month. Modified Fibromyalgia Impact Questionnare (FIQR), Brief pain inventory (BPI), Medical Outcomes study (MOS) sleep scale score, Sheehan Disability Scale (SDS) score will be recorded in case record forms at baseline, 2 months of treatment and 3 months of treatment. Safety of milnacipran and pregabalin will be assessed through out the study by monitoring Adverse Drug Reactions and causality will be assessed using WHO Adverse Drug reaction monitoring criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Subjects diagnosed as having fibromyalgia according to 2010 ACR diagnostic criteria for fibromyalgia.

Exclusion Criteria

• 1.Subjects not willing to take part in the study.
• 2.Major depressive or psychiatric disorder, suicidal tendency or ideation.
• 3.Pregnancy 4.Lactation 5.Uncontrolled hypertension 6.Hepatic dysfunction 7.History of glaucoma 8.Patients receiving MAO inhibitors (eg: selegeline) 9.Cardiac failure (NYHA class III-IV).

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in modified Fibromyalgia Impact Questionnare (FIQR)score from baseline.	2 months, 3 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Medical Outcomes Study (MOS) sleep scale score from baseline.	2 months, 3 months of treatment.
Change in Sheehan Disability scale (SDS) score from baseline.	2 months, 3 months of treatment.
Analysis of symptoms and laboratory abnormalities associated with fibromyalgia.	Baseline
Incremental cost effectiveness ratio (ICER) of treatment regimens	2 months, 3 months
Comparison of absolute Fibromyalgia Impact Questionnare (FIQR)score	Baseline, 2 months, 3 months of treatment.
Comparison of absolute brief pain inventory (BPI) score.	Baseline, 2 months, 3 months of treatment.
Comparison of absolute Medical Outcomes Study (MOS) sleep scale score.	Baseline, 2 months, 3 months of treatment.
Comparison of absolute Sheehan Disability scale (SDS) score.	Baseline, 2 months, 3 months of treatment.
Change in brief pain inventory (BPI) score from baseline.	2 months, 3 months of treatment.
Adverse events associated with milnacipran and pregabalin	Through out the study
Discontinuation of study medications and reason for discontinuation.	Through out the study

Trial Locations

Locations (1)

Sree Gokulam Medical College and Research Foundation; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Gokulam Medical College and Research Foundation

🇮🇳Thiruvananthapuram, KERALA, India

NIRMAL GEORGE

Principal investigator

8129900220

nirmalgeorge.ng@gmail.com