Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis
Primary Purpose
Liver Cirrhosis, Muscle Cramps
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
orphenadrine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Cirrhosis
- Muscle cramps( ≥3 cramps per week )
Exclusion Criteria:
• 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
Sites / Locations
- Tanta university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Orphenadrine(Norflex)
Placebo
Arm Description
50 patients will be treated with orphenadrine 100 mg twice daily for 1 month
50 patients will be given placebo
Outcomes
Primary Outcome Measures
Frequency of muscle cramps
questionnaire
Secondary Outcome Measures
Quality of life of these patients
questionnaire
Full Information
NCT ID
NCT02423395
First Posted
April 15, 2015
Last Updated
June 6, 2019
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT02423395
Brief Title
Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis
Official Title
Randomized Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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]
Detailed Description
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].
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking [2].
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] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.[5]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Muscle Cramps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orphenadrine(Norflex)
Arm Type
Experimental
Arm Description
50 patients will be treated with orphenadrine 100 mg twice daily for 1 month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50 patients will be given placebo
Intervention Type
Drug
Intervention Name(s)
orphenadrine
Other Intervention Name(s)
Norflex
Intervention Description
Orphenadrine in muscle cramps in cirrhotic patients
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
calcium
Intervention Description
calcium in muscle cramps in cirrhotic patients
Primary Outcome Measure Information:
Title
Frequency of muscle cramps
Description
questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life of these patients
Description
questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cirrhosis
Muscle cramps( ≥3 cramps per week )
Exclusion Criteria:
• 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M Abd-Elsalam, lecturer
Phone
01000058842
Ext
002
Email
Sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, Professor
Organizational Affiliation
TUH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samah Mosaad, Lecturer
Organizational Affiliation
TUH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lobna Aboaly, Professor
Organizational Affiliation
TUH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walaa ElKhalawany, Lecturer
Organizational Affiliation
TUH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Lecturer
Organizational Affiliation
TUH
Official's Role
Study Director
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31834056
Citation
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.
Results Reference
derived
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Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis
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