Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

NCT02221570 | Unknown DMC

• 1 other identifier: baclofen cramps
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life. The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Conditions

Muscle Cramps; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.

  3 months

Study Arms (2)

Baclofen

ACTIVE COMPARATOR

Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.

Drug: Baclofen

Placebo

PLACEBO COMPARATOR

placebo of baclofen

Interventions

Baclofen DRUG

Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.

Also known as: Gablofen, Lioresal, Apo-Baclofen, Dom-Baclofen, Liotec, Med-Baclofen, Mylan-Baclofen, Novo-Baclofen, Nu-Baclo, PHL-Baclofen, PMS-Baclofen, ratio-Baclofen, Riva-Baclofen

Baclofen

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, Egypt

RECRUITING

Related Publications (7)

• Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.

  PMID: 22835465 BACKGROUND

• Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.

  PMID: 23542334 BACKGROUND

• Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. doi: 10.1136/bmj.4.5778.15.

  PMID: 4938243 BACKGROUND

• Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. doi: 10.1007/s11916-001-0014-1.

  PMID: 11252142 BACKGROUND

• Orr WC, Goodrich S, Wright S, Shepherd K, Mellow M. The effect of baclofen on nocturnal gastroesophageal reflux and measures of sleep quality: a randomized, cross-over trial. Neurogastroenterol Motil. 2012 Jun;24(6):553-9, e253. doi: 10.1111/j.1365-2982.2012.01900.x. Epub 2012 Mar 8.

  PMID: 22404184 BACKGROUND

• Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. doi: 10.1056/NEJM198811173192016. No abstract available.

  PMID: 3185643 BACKGROUND

• Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.

  PMID: 20655477 BACKGROUND

MeSH Terms

Conditions

Muscle Cramp; Liver Cirrhosis

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Asem A Elfert, MD

  Tanta Faculty of Medicine, Professor

  PRINCIPAL INVESTIGATOR

• Lobna A AboAli

  Tanta Faculty of Medicine, Lecturer

  STUDY DIRECTOR

• Samah M Soliman

  Tanta Faculty of Medicine, Lecturer

  STUDY DIRECTOR

• Ibrahim Shebl

  Tanta University Hospitals, House Officer

  STUDY DIRECTOR

Central Study Contacts

Asem A Elfert, MD

CONTACT

+20-122-437-8188; asem1967@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 20, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 6, 2014

Record last verified: 2014-10

Locations

EG (1)