NCT02642861

Brief Summary

\- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2.8 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

December 25, 2015

Last Update Submit

December 30, 2017

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of muscle cramps

    The number of muscle cramps

    3 months

Study Arms (2)

Cyclobenzaprine

ACTIVE COMPARATOR

Cyclobenzaprine administration for 2 weeks

Drug: Cyclobenzaprine

PLacebo

PLACEBO COMPARATOR

Calcium carbonate for 2 weeks

Drug: Calcium Carbonate

Interventions

CyclobenzaprineDRUG

cyclobenzaprine administration for 2 weeks

Also known as: cyclosed
Cyclobenzaprine
Calcium CarbonateDRUG

Calcium carbonate for 2 weeks

Also known as: Calcitron
PLacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Liver cirrhosis and has frequent muscle cramps

You may not qualify if:

  • Allergy to cyclobenzaprine
  • Encephalopathy.
  • Receiving antidepressant drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

cyclobenzaprineCalcium Carbonate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Sherief M. Abd-Elsalam, Consultant

    liver diseases dept.- Tanta university hospital

    PRINCIPAL INVESTIGATOR

  • Walaa A. Elkhalawany, Consultant

    liver diseases dept.- Tanta university hospital

    STUDY DIRECTOR

Central Study Contacts

Sherief M. Abd-Elsalam, Consultant

CONTACT

00201095159522sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant liver and GIT diseases- Tanta university hospital

Study Record Dates

First Submitted

December 25, 2015

First Posted

December 30, 2015

Study Start

October 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

EG(1)