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

Effectiveness and safety of pregabalin versus milnacipran in patients with fibromyalgia â?? A randomized open label post marketing study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/03/008113

Enrollment

Registered

2017-03-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M797- Fibromyalgia Health Condition 2: null- Patients diagnosed with fibromyalgia using modified ACR 2010 criteria

Interventions

Intervention1: Milnacipran: 50-100mg/day orally (stable dose) Control Intervention1: Pregabalin: 150-300 mg/day orally (stable dose)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects diagnosed as having fibromyalgia according to 2010 ACR diagnostic criteria for fibromyalgia

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Change in modified Fibromyalgia Impact Questionnare (FIQR)score from baseline.Timepoint: 2 months, 3 months of treatment.	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactNirmal George

Sree Gokulam Medical College and Research Foundation

nirmalgeorge.ng@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026