Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04727502
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2020-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Duloxetine Versus Pregabalin
Sponsor:
National Cancer Institute, Egypt
Organization:
Study Overview
Official Title:
Comparison of Duloxetine Versus Pregabalin in Post-mastectomy Pain Syndrome: a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 identiļ¬ed 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
* 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: