Orphenadrine Versus Baclofen in Treatment of Muscle Cramp... | NCT04509336

Studies
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

NCT04509336

Sponsor

Mansoura University

Status

Terminated

Last Update Posted

Apr 29, 2022Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Cirrhosis

Interventions

Orphenadrine
Baclofen

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID 19 Pandemic

Expanded Access Info

Start Date

Aug 20, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Sep 20, 2021Actual

First Submitted Date

Jul 21, 2020

First Submission Date that Met QC Criteria

Aug 10, 2020

First Posted Date

Aug 12, 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

Apr 27, 2022

Last Update Posted Date

Apr 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Noha Mansour, Lecturer of clinical pharmacy, pharmacy practice department, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.

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

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
orphenadrine group	Experimental	orphenadrine	Drug: Orphenadrine
Baclofen group	Active Comparator	Baclofen	Drug: Baclofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orphenadrine	Drug	100 mg twice daily	orphenadrine group
Baclofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment	Questionnaire	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment	Visual analogue scale (VAS)	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years
Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month

Exclusion Criteria:

Patients with allergy to study drugs
Renal impairment
Peripheral vascular disease
Peripheral neuropathy
Glaucoma
Prostatic enlargement
Pregnancy and lactation
Patients taking calcium channel blockers, and conjugated estrogens
Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
Patients with alcoholic cirrhosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

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

Not provided

Overall Officials

Name	Affiliation	Role
Assem Elfert	Tanta University	Study Chair
Sherif Abd-Elsalam	Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University Hospitals		Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009966	Orphenadrine
D001418	Baclofen

Ancestor Terms

ID	Term
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals
D001559	Benzhydryl Compounds

Browse Leaves

Not provided

Browse Branches

Not provided