Comparison of Duloxetine Versus Pregabalin

Drug Effect Clinical Trial

Official title:

Comparison of Duloxetine Versus Pregabalin in Post-mastectomy Pain Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727502
• Other study ID #: AP2007-50104
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2020
• Est. completion date: April 2021

Study information

• Verified date: January 2021
• Source: National Cancer Institute, Egypt
• Contact: Mohamed Abdel Wadod, MD
• Phone: +201006645981
• Email: m_wadod[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Patients with of 3 months of chronic neuropathic pain after breast surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection is considered as post mastectomy pain syndrome which is defined as pain involving the anterior aspect of the chest, axilla, and/or upper arm with the classical features of neuropathic pain including numbness, tingling, burning, shooting, stinging, or stabbing pains, and hyperesthesia.

• They are divided to 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 )

• Randomization and blinding: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.

• Concomitant therapy :opioid therapy according to WHO step ladder in cancer pain

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Drug Effect

Intervention

Drug:
• Duloxetine
duloxetine
• Pregablin
Pregablin

Locations

Country	Name	City	State
Egypt	Nataional Cancer Instituite	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue score	visual analogue score with least pain score is 0 and worst pain is 10	baseline till 12 weeks of treatment