NCT02423395

Brief Summary

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \[3,4\]

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
31mo left

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress82%
Jan 2015Dec 2028

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

13.9 years

First QC Date

April 15, 2015

Last Update Submit

June 6, 2019

Conditions

Liver CirrhosisMuscle Cramps

Outcome Measures

Primary Outcomes (1)

  • Frequency of muscle cramps

    questionnaire

    3 months

Secondary Outcomes (1)

  • Quality of life of these patients

    3 months

Study Arms (2)

Orphenadrine(Norflex)

EXPERIMENTAL

50 patients will be treated with orphenadrine 100 mg twice daily for 1 month

Drug: orphenadrine

Placebo

PLACEBO COMPARATOR

50 patients will be given placebo

Drug: Placebo

Interventions

orphenadrineDRUG

Orphenadrine in muscle cramps in cirrhotic patients

Also known as: Norflex
Orphenadrine(Norflex)
PlaceboDRUG

calcium in muscle cramps in cirrhotic patients

Also known as: calcium
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis
  • Muscle cramps( ≥3 cramps per week )

You may not qualify if:

  • Allergy to orphenadrine
  • Renal impairment
  • Pregnant and lactating women
  • Peripheral vascular disease
  • Peripheral neuropathy
  • Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital

Tanta, Egypt

RECRUITING

Related Publications (1)

  • Abd-Elsalam S, Ebrahim S, Soliman S, Alkhalawany W, Elfert A, Hawash N, Elkadeem M, Badawi R. Orphenadrine in treatment of muscle cramps in cirrhotic patients: a randomized study. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):1042-1045. doi: 10.1097/MEG.0000000000001622.

    PMID: 31834056DERIVED

MeSH Terms

Conditions

Liver CirrhosisMuscle Cramp

Interventions

OrphenadrineCalcium

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

EthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Asem A Elfert, Professor

    TUH

    PRINCIPAL INVESTIGATOR

  • Samah Mosaad, Lecturer

    TUH

    STUDY CHAIR

  • Lobna Aboaly, Professor

    TUH

    STUDY CHAIR

  • Walaa ElKhalawany, Lecturer

    TUH

    STUDY CHAIR

  • Sherief Abd-Elsalam, Lecturer

    TUH

    STUDY DIRECTOR

Central Study Contacts

Sherief M Abd-Elsalam, lecturer

CONTACT

01000058842Sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 22, 2015

Study Start

January 1, 2015

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)