We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis

This study is currently recruiting participants.
Verified May 2016 by Sherief Abd-Elsalam, Tanta University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02423395
First Posted: April 22, 2015
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University
  Purpose
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]

Condition Intervention Phase
Liver Cirrhosis Muscle Cramps Drug: orphenadrine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis

Resource links provided by NLM:


Further study details as provided by Sherief Abd-Elsalam, Tanta University:

Primary Outcome Measures:
  • Frequency of muscle cramps [ Time Frame: 3 months ]
    questionnaire


Secondary Outcome Measures:
  • Quality of life of these patients [ Time Frame: 3 months ]
    questionnaire


Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orphenadrine(Norflex)
100 patients will be treated with orphenadrine 100 mg twice daily for 1 month
Drug: orphenadrine
Orphenadrine in muscle cramps in cirrhotic patients
Other Name: Norflex
Placebo Comparator: Placebo
100 patients will be given placebo
Drug: Placebo
calcium in muscle cramps in cirrhotic patients
Other Name: calcium

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]

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423395


Contacts
Contact: Sherief M Abd-Elsalam, lecturer 01000058842 ext 002 Sherif_tropical@yahoo.com

Locations
Egypt
Tanta university hospital Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
Principal Investigator: Asem A Elfert, Professor TUH
Study Chair: Samah Mosaad, Lecturer TUH
Study Chair: Lobna Aboaly, Professor TUH
Study Chair: Walaa ElKhalawany, Lecturer TUH
Study Director: Sherief Abd-Elsalam, Lecturer TUH
  More Information

Responsible Party: Sherief Abd-Elsalam, Study director, Tanta University
ClinicalTrials.gov Identifier: NCT02423395     History of Changes
Other Study ID Numbers: muscle cramps in cirrhotics
First Submitted: April 15, 2015
First Posted: April 22, 2015
Last Update Posted: May 30, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Muscle Cramp
Spasm
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orphenadrine
Antiparkinson Agents
Anti-Dyskinesia Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors