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Status unknownNCT02221570Updated Oct 6, 2014

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

An interventional study of Baclofen in Muscle Cramps and Liver Cirrhosis, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-06.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Muscle Cramps
  • Liver Cirrhosis
03

In context

Muscle Cramp

95 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 85 interventional studies indexed under Muscle Cramp.

Browse Muscle Cramp studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Baclofen

    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 comparator
    Placebo

    placebo of baclofen

Interventions

  • DrugBaclofen

    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

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What researchers measure

Primary outcomes

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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Tanta University Hospital
    Tanta, Gharbia, Egypt
    • Asem A Elfert, MD · Contact · asem1967@yahoo.com · +20-122-437-8188
    • Asem A Elfert, MD · Principal investigator
    Recruiting
08

References and documents

Publications

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02221570
Lead sponsor
Tanta University
Responsible party
Ibrahim Shebl (Dr., Tanta University) — Principal investigator
First posted
Aug 20, 2014
Start date
Jun 2014
Primary completion
Nov 2014 (estimated)
Completion
Nov 2014 (estimated)
Last update
Oct 6, 2014

Study contacts

Asem A Elfert, MD
Contact
asem1967@yahoo.com
+20-122-437-8188
Asem A Elfert, MD
principal investigator · Tanta Faculty of Medicine, Professor
Lobna A AboAli
study director · Tanta Faculty of Medicine, Lecturer
Samah M Soliman
study director · Tanta Faculty of Medicine, Lecturer
Ibrahim Shebl
study director · Tanta University Hospitals, House Officer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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