Clinical trial NCT02423395: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver Cirrhosis
Muscle Cramps
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2015-04-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.\[5\]

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

Primary outcomes:
measure: Frequency of muscle cramps
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life of these patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: TUH
name: Asem A Elfert, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: TUH
name: Samah Mosaad, Lecturer
role: STUDY_CHAIR
affiliation: TUH
name: Lobna Aboaly, Professor
role: STUDY_CHAIR
affiliation: TUH
name: Walaa ElKhalawany, Lecturer
role: STUDY_CHAIR
affiliation: TUH
name: Sherief Abd-Elsalam, Lecturer
role: STUDY_DIRECTOR
References:
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.