Pilot Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02423395|
Recruitment Status : Unknown
Verified May 2016 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was: Recruiting
First Posted : April 22, 2015
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Muscle Cramps||Drug: orphenadrine Drug: Placebo||Phase 3|
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 .
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 .
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pilot Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
100 patients will be treated with orphenadrine 100 mg twice daily for 1 month
Orphenadrine in muscle cramps in cirrhotic patients
Other Name: Norflex
Placebo Comparator: Placebo
100 patients will be given placebo
calcium in muscle cramps in cirrhotic patients
Other Name: calcium
- Frequency of muscle cramps [ Time Frame: 3 months ]questionnaire
- Quality of life of these patients [ Time Frame: 3 months ]questionnaire
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
|Contact: Sherief M Abd-Elsalam, lecturer||01000058842 ext 002||Sherif_tropical@yahoo.com|
|Tanta university hospital||Recruiting|
|Contact: Sherief Abd-Elsalam 00201000040794 Sherif_tropical@yahoo.com|
|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|