Gabapentin in Treatment of Muscle Cramps in Patients With... | NCT02642484

Studies
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

NCT02642484

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Jan 3, 2018Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Liver Cirrhosis

Interventions

Gabapentin
Calcium Carbonate

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2018Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Dec 24, 2015

First Submission Date that Met QC Criteria

Dec 24, 2015

First Posted Date

Dec 30, 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

Dec 30, 2017

Last Update Posted Date

Jan 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 markedly affect the quality of life in cirrhotic patients with no highly effective drug.
Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.

Detailed Description

• The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin	Active Comparator	Gabapentin twice daily	Drug: Gabapentin
PLacebo	Placebo Comparator	Calcium carbonate twice daily	Drug: Calcium Carbonate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	Gapapentin twice daily	Gabapentin	Gaptin

Measure	Description	Time Frame
Number of muscle cramps		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver cirrhosis patients

Exclusion Criteria:

allergy to gapabentin.
pregnancy and lactation. Renal failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief M. Abd-Elsalam, Consultant	Contact	00201095159522		sherif_tropical@yahoo.com

Overall Officials

Name	Affiliation	Role
Sherief M. Abd-Elsalam, Consultant	Hepatology and gastroenterology dept.-Tanta	Principal Investigator
A. K. Singal, Professor	Division of Gastroenterology and Hepatology, UAB, Birmingham, AL, USA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta university - faculty of medicine		Tanta	Elgharbia		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

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin
D002119	Calcium Carbonate

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided