Efficacy of Palmitoylethanolamide-polydatin Combination o... | NCT02372903

Studies
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis

NCT02372903

Sponsor

University of Cagliari

Status

Completed

Last Update Posted

Nov 4, 2016Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Endometriosis
Chronic Pelvic Pain

Interventions

Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

Countries

Italy

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Feb 13, 2015

First Submission Date that Met QC Criteria

Feb 21, 2015

First Posted Date

Feb 26, 2015Estimated

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

Nov 3, 2016

Last Update Posted Date

Nov 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia.

N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endometriosis	Experimental	Symptomatic patients with laparoscopic diagnosis of endometriosis	Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin	Drug	Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Pelvic pain as measured by visual analogue scale		Change from Baseline Pelvic Pain at 90 days of treatment

Secondary Outcomes

Measure	Description	Time Frame
Change of Pelvic pain as measured by visual analogue scale		Change from baseline Pelvic Pain after 30 days from the suspension of the therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18 and 50 years;
pain visual analog scale (VAS) score>4
laparoscopic diagnosis of endometriosis (performed in the last three years),
no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists)
persistence of symptoms by at least one month

Exclusion Criteria:

presence of other associated diseases
assumption of drugs
menopause
pregnancy
unable or unwilling to give written consent patients
adverse reaction or hypersensitivity to active substance or excipients

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cagliari,Obstetrics and Gynecological Department,		Monserrato	Cagliari	09042	Italy

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided