Comparison of Duloxetine Versus Pregabalin | NCT04727502

Studies
Comparison of Duloxetine Versus Pregabalin

NCT04727502

Sponsor

National Cancer Institute, Egypt

Status

Unknown status

Last Update Posted

Jan 27, 2021Actual

Enrollment

70Estimated

Phase

Phase 2

Conditions

Drug Effect

Interventions

Duloxetine
Pregablin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2020Actual

Primary Completion Date

Mar 2021Estimated

Completion Date

Apr 2021Estimated

First Submitted Date

Dec 25, 2020

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Jan 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammed Abdelfattah Abdelwadod, Mohammed Abdelfattah Abdelwadod, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
( 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

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug	duloxetine	( Group Duloxetine )
Pregablin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual analogue score	visual analogue score with least pain score is 0 and worst pain is 10	baseline till 12 weeks of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Adult female patients underwent breast cancer surgeries presented with post mastectomy pain syndrome

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Abdel Wadod, MD	Contact	+201006645981		m_wadod@yahoo.com
Wala yousef, Md	Contact	+201007798466		wala_70s@hotmail.com

Overall Officials

Name	Affiliation	Role
Mohamed Abdel Wadod, MD	National Cancer Institute, Cairo University, Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nataional Cancer Instituite	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068736	Duloxetine Hydrochloride

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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

Masking Info

Masking

Double

Masking Description

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

Who Masked

Care ProviderOutcomes Assessor