Comparison of Duloxetine Versus Pregabalin

NCT04727502 | Unknown Phase 2

• 1 other identifier: AP2007-50104
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic post mastectomy pain syndrome (PMPS) is a chronic post-surgical neuropathic pain following breast cancer surgeries and lasting more than three months after surgeries. Pregabalin is originally used as an antiepileptic drug and identified as treatment for neuropathic pain .There are several recent reviews have revealed that it reduces post-operative opioid consumption and improves pain scores after breast surgeries. Duloxetine is a serotonin and norepinephrine reuptake inhibitor. Its mechanism of action is related to the potentiation of serotonergic and noradrenergic activity in the descending inhibitory pain pathways of the central nervous system and used for treatment of neuropathic pain conditions as painful diabetic neuropathy, neuropathic pain of lung cancer and chemotherapy induced sensory neuropathy

Conditions

Drug Effect

Keywords

pregabalin and Duloxetine

Outcome Measures

Primary Outcomes (1)

• visual analogue score

  visual analogue score with least pain score is 0 and worst pain is 10

  baseline till 12 weeks of treatment

Study Arms (2)

( Group Duloxetine )

ACTIVE COMPARATOR

• Dosing and administration (Group A) Duloxetine 30 mg /day oral intake at bed time

Drug: Duloxetine

(Group Pregablin )

ACTIVE COMPARATOR

control group Pregablin 150mg /day( 75 mg /12 hours ) oral intake.

Drug: Pregablin

Interventions

Duloxetine DRUG

duloxetine

( Group Duloxetine )

Pregablin DRUG

Pregablin

(Group Pregablin )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Adult female patients underwent breast cancer surgeries presented with post mastectomy pain syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, history of breast surgery and patients with post mastectomy pain

You may not qualify if:

• pregnancy,history of allergy to Pregabalin or duloxetine, pregnancy or lactation, history of pregabalin or gabapentin intake in the preceding three months, history of radiotherapy and history of drug abuse

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Nataional Cancer Instituite

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed Abdel Wadod, MD

  National Cancer Institute, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Abdel Wadod, MD

CONTACT

+201006645981; m_wadod@yahoo.com

Wala yousef, Md

CONTACT

+201007798466; wala_70s@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohammed Abdelfattah Abdelwadod

Model Details: 2 equal groups ( Group A) :receive duloxetine for 12 weeks and (Group B) control group receive pregabalin for 12 weeks . • Dosing and administration Group A) Duloxetine 30 mg /day at bed time and (Group B) control group Pregablin 150mg /day( 75 mg /12 hours

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: January 27, 2021
• Study Start: December 20, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

EG (1)