search
Back to results

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

Primary Purpose

Muscle Cramps, Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Baclofen
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Cramps

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Tanta University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Baclofen

Placebo

Arm Description

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.

placebo of baclofen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2014
Last Updated
October 2, 2014
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT02221570
Brief Title
Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Official Title
A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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. 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. 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. The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Cramps, Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baclofen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo of baclofen
Intervention Type
Drug
Intervention Name(s)
Baclofen
Other Intervention Name(s)
Gablofen, Lioresal, Apo-Baclofen, Dom-Baclofen, Liotec, Med-Baclofen, Mylan-Baclofen, Novo-Baclofen, Nu-Baclo, PHL-Baclofen, PMS-Baclofen, ratio-Baclofen, Riva-Baclofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cirrhosis Muscle cramps( ≥3 cramps per week ) Exclusion Criteria: Allergy to baclofen Renal impairment Pregnant and lactating women Peripheral vascular disease Peripheral neuropathy Medications as calcium channel blockers, conjugated estrogens and naproxen.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lobna A AboAli
Organizational Affiliation
Tanta Faculty of Medicine, Lecturer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samah M Soliman
Organizational Affiliation
Tanta Faculty of Medicine, Lecturer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibrahim Shebl
Organizational Affiliation
Tanta University Hospitals, House Officer
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Gharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22835465
Citation
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.
Results Reference
background
PubMed Identifier
23542334
Citation
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.
Results Reference
background
PubMed Identifier
4938243
Citation
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.
Results Reference
background
PubMed Identifier
11252142
Citation
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.
Results Reference
background
PubMed Identifier
22404184
Citation
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.
Results Reference
background
PubMed Identifier
3185643
Citation
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.
Results Reference
background
PubMed Identifier
20655477
Citation
Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.
Results Reference
background

Learn more about this trial

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

We'll reach out to this number within 24 hrs