Comparison of Duloxetine Versus Pregabalin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2021-04-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Drug Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.

Study Groups

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( Group Duloxetine )

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

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

duloxetine

(Group Pregablin )

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

Group Type ACTIVE_COMPARATOR

Pregablin

Intervention Type DRUG

Pregablin

Interventions

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Duloxetine

duloxetine

Intervention Type DRUG

Pregablin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No