Comparative Analysis of the Effectiveness of the Use of N... | NCT04609748

Studies
Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.

NCT04609748

Sponsor

Pomeranian Medical University Szczecin

Status

Unknown status

Last Update Posted

Jan 29, 2021Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Joint Pain

Interventions

Cannabidiol Oil
Nimesulide

Countries

Poland

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

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

Jan 27, 2021Actual

Primary Completion Date

Jul 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Oct 26, 2020

First Submission Date that Met QC Criteria

Oct 26, 2020

First Posted Date

Oct 30, 2020Actual

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 29, 2021Actual

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

During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.

Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The group that received nimesulide	Active Comparator		Drug: Nimesulide
The group that received CBD Oil	Experimental		Drug: Cannabidiol Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cannabidiol Oil	Drug	Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.	The group that received CBD Oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain relief	Measured on Visual Analogue Scale (VAS) scale. It consists of a line, approximately 100mm in length, at the left end of the scale "Score 0" which means "no pain", at the right end of the scale "Score 100mm" which means "worst imaginable pain"	15 days
Psychological conditions	Measured on The General Health Questionnaire-28 (GHQ-28)	15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (female and male) aged 18-65 years, able to swallow tablets
Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
Patients with clinical diagnosis of Temporomandibular Joint Dysfunction

Exclusion Criteria:

patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
patients allergic to nimesulide or cannabidiol oil
patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:
- gastric or duodenal ulcer disease,
- severe blood clotting disorders,
- severe liver dysfunction,
- severe renal impairment,
- severe heart failure, pregnancy,
- breastfeeding,
- concomitant intake of citrochrome blockers CYP3A4 or CYPP2D6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, SSRI, tricyclic antidepressants, opioids)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bartosz Dalewski, DMD, PhD	Contact	914661717		bartosz.dalewski@pum.edu.pl
Kamila Szczuchniak, DMD	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chair and Depratment of Dental Prosthetics	Recruiting	Szczecin			Poland

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases
D009135	Muscular Diseases
D009057	Stomatognathic Diseases
D009209	Myofascial Pain Syndromes

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Term
D013705	Temporomandibular Joint Disorders
D013706	Temporomandibular Joint Dysfunction Syndrome