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Clinical Trials/CTRI/2022/02/040438
CTRI/2022/02/040438
Completed
Phase 4

A post-marketing surveillance study to assess the safety and efficacy of Pregabalin IP 75 mg and Nortriptyline 10 mg Tablets in diabetic peripheral neuropathy

Micro Labs Limited0 sites203 target enrollmentTBD
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ConditionsHealth Condition 1: G64- Other disorders of peripheral nervous system

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: G64- Other disorders of peripheral nervous system
Sponsor
Micro Labs Limited
Enrollment
203
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
May 23, 2022
Last Updated
3 years ago
Study Type
Pms

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Presence of type 2 diabetes mellitus
  • •2\. No change in anti\-diabetic medication for the past 1 month
  • •3\. Evidence of painful diabetic neuropathy by:
  • •i.Neuropathic pain present for at least 1 month.
  • •ii.Mean pain intensity of more than 50% by patient assessment by NRS (numerical rating scale)
  • •4\. Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed

Exclusion Criteria

  • •1\. Pregnancy and lactation.
  • •2\. Subjects having intolerance, hypersensitivity or any other contraindication to any of the Investigational products.
  • •3\. Evidence of other causes for neuropathy and painful conditions
  • •4\. Epilepsy, psychiatric and cardiac diseases, hypertensives not on treatment, peripheral vascular disease and substance abuse.
  • •5\. Intake of any other anticonvulsants, antidepressants, membrane stabilizers and opioid
  • •6\. Patients who have participated in another clinical study in the past 3 months prior to commencement of this study
  • •7\. Subjects judged unfit for this study by investigator.

Outcomes

Primary Outcomes

Not specified

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