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An observational study to check if Pregabalin-Duloxetine combination is safe and effective in neuropathic pain and how it is utilized in in that condition

A Retrospective, Observational, Case cohort, Multicenter Study to Assess the Safety, Effectiveness & Utilization Pattern of Pregabalin-Duloxetine FDC in Neuropathic pain (ROME Study) - ROME

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093352
Enrollment
10000
Registered
2025-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications Health Condition 2: G60-G65- Polyneuropathies and other disorders of the peripheral nervous system

Interventions

Intervention1: Nil: N/A

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients suffering from Neuropathic Pain and treated with Pregabalin-Duloxetine FDC 2. Patients followed-up for 12 weeks 3. Patients having at least 1 reported follow-up visits by 3 months following dose/therapy initiation [Baseline, Visit-1(Follow-up)].

Exclusion criteria

Exclusion criteria: 1. Cases with incomplete medical records

Design outcomes

Primary

MeasureTime frame
1. Occurrence of AE/SAE/Discontinuation from PGB-DUL FDC therapy 2. Change in VAS score from baseline to 12th weekTimepoint: Baseline and 12 weeks—

Secondary

MeasureTime frame
1. To assess usage pattern of PGB-DUL FDC in management of neuropathic pain 2. To assess more than or equal to 50% improvement in pain 3. Change in CGI-I Scale from baseline to 12th weekTimepoint: Baseline & 12 weeks—

Countries

India

Contacts

Public ContactYakshdeep Dave

Torrent Pharmaceuticals Ltd.

zahraanqureshi@torrentpharma.com7069000629

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026