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Study to check the effect of combination treatment of Pregabalin/Duloxetine in patients with Nerve Pain

ââ?¬Å?Post-approvaL, concurrent, observational Study to assess clinical effectiveness and safety of Pregabalin/Duloxetine In moderate to severe Neuropathic pain syndrome - PREVALENCE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/05/042471
Enrollment
10000
Registered
2022-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: M792- Neuralgia and neuritis, unspecified

Interventions

None listed

Sponsors

Torrent Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � Male or female patients 18 to 59 years � Newly diagnosed cases of peripheral Neuropathic pain with NRS scale score more than or equla to 4 � Known cases of peripheral Neuropathic pain with NRS scale score more than or equal to 4 receiving stable doses of Gabapentinoid based therapy for at least four weeks � Patients willing follow-up for 4 W at the same centre

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to individual ingredients 2. Unstable or untreated cases of Mood disorders or T2DM (HbA1c more than 9 percent and symptomatic requiring insulin therapy 3. CKD with eGFR less than 30 ml per min 4. clinically significant electrocardiogram (ECG) abnormalities or QTc more than or equal to 450 msec, 5. liver enzymes, ALT or AST more than 3X, ALP more than 2.5X or ULN (upper limit of normal) or total bilirubin more than 1.5X of ULN, 6. serum sodium level less than 130 mmol per L, 7. DKA and/or history of DKA that required hospitalization 8. For women only currently pregnant (confirmed with positive pregnancy test) or breast-feeding 9. Type 1 diabetes mellitus patients 10. Sexually active woman of childbearing age not practicing accepted birth control method 11. Any other medication for pain control during the observation period other than acetaminophen used as rescue medication

Design outcomes

Primary

MeasureTime frame
To assess clinical effectiveness and safety of Pregabalin/Duloxetine In moderate to severe Neuropathic pain syndromeTimepoint: At baseline and 4 weeks—

Secondary

MeasureTime frame
1. Mean changes from baseline in pain DETECT score for Neuropathic pain cases at 4W 2. Proportion of patients requiring Rescue medications at 4W 3. Safety assessment for Common Adverse events (more than 1%) at 4WTimepoint: Baseline (Day 0) and 4 weeks—

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Torrent Pharmaceuticals Ltd

KrishnaprasadKorukonda@torrentpharma.com

Outcome results

None listed

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