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Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: 30 to 100
    • Primary and study completion dates: Dec 2018 to Dec 2028
    • Study title shortened, about 1 word
    v6
  2. Enrollment target: 200 to 30
    • Primary and study completion dates: Dec 2016 to Dec 2018
    • Study title shortened, about 3 words
    v5
  3. Primary completion date: Apr 2016 to Dec 2016v4
  4. Primary completion date: Oct 2015 to Apr 2016
    • Study completion date: Dec 2015 to Dec 2016
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. \[3,4\]
Trial Details
NCT Number NCT02423395
Lead Sponsor Sherief Abd-Elsalam
Collaborators: Tanta University
Conditions
(from sponsor)		 Liver Cirrhosis, Muscle Cramps
Related terms Liver Cirrhosis, Muscle Cramp
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov