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Trial record 1 of 1 for:    NCT01271660
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A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01271660
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 7, 2011
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE July 2011
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
Difference in the frequency of muscle cramps between run-in and treatment phases (/week) [ Time Frame: after 4 weeks of standard dose treatment period ]
The frequency is defined as muscle cramps per week.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
mean reduction rates of the frequency of muscle cramps between pregabalin and placebo groups [ Time Frame: after 4 weeks of standard dose treatment period ]
Definition of the reduction rate of the frequency of muscle cramps is defined as [(a total number of muscle cramps during the run-in period) - (a total number of muscle cramps during the standard dose treatment period)] divided by [(a total number of muscle cramps during the run-in period)]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
Response rates , Mean change in the average cramp pain intensity , peripheral nerve excitability , the quality of life, quality of sleep , safety [ Time Frame: after 4 weeks of standard dose treatment period or over a 6-week treatment period ]
Response rates : the proportion (%) of patients showing ≥50% reduction in the number of muscle cramps. Mean change in the average cramp pain intensity : a sum of the pain rating scale divided by a total number of muscle cramps. Peripheral nerve excitability as measured by nerve stimulation test. The quality of life as measured by mean change in the score of the SF-36. Quality of sleep as measured by mean change in the number of muscle cramps during sleep. Safety as measured by dose-reduction or discontinuation rates, treatment-emergent adverse events, and vital signs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis
Official Title  ICMJE A Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of 6-week Treatment of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis
Brief Summary

Muscle cramp is defined as a paroxysmal, involuntary, and painful contraction of skeletal muscle. Cirrhotic patients can encounter with muscle cramp frequently, which might be associated with poor quality of life. Gabapentin can be prescribed for muscle cramp. However, patients with liver cirrhosis have limited access to gabapentin which is metabolized primarily in liver.

Pregabalin with a similar mechanism of action to gabapentin undergoes negligible metabolism owing to its improved pharmacokinetic properties. Thus, pregabalin might be a promising therapeutic option for patients with liver cirrhosis who are suffering from muscle cramp and susceptible to drug-induced hepatotoxicity.

Therefore, the investigators hypothesize that pregabalin could effectively reduce painful symptoms derived from muscle cramp. In the current study, the investigators are going to evaluate the efficacy and safety of pregabalin by comparing outcomes between two groups (treatment group vs. placebo group).

Detailed Description The investigators are planning to recruit patients with liver cirrhosis and muscle cramp, and collect the baseline clinical and laboratory data during the 4-week run-in period for each subject. After a run-in period, there will be the second step of patient selection to achieve a more homogenous study population. Then, patients will be randomly allocated into the treatment (pregabalin) and placebo (dummy) arms, by a web-based randomization program. After a treatment period (75 mg twice daily during the first 1 week as titration, 150 mg twice daily for 4 weeks as standard dose), the investigators will gather further study information of a standard dose period (150mg twice daily for 4 weeks) from the target population and the study subjects will enter the 1-week tapering period (75mg twice a day) to discontinuation. The primary outcome will be the difference in the frequency of muscle cramps between the run-in and treatment phases. The investigators also intend to assess the response rate, defined as the proportion (%) of patients showing ≥50% reduction in the number of muscle cramps, mean change in the average pain intensity, mean change in the score of the Short Form 36 (SF-36, QualityMetric) health survey questionnaire, mean change in the frequency of muscle cramps during sleep, and mean change in the average cramp threshold frequency by the neurophysiologic study (nerve excitability test) and analyze the reasons for drop-out cases.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Muscle Cramp
  • Liver Cirrhosis
Intervention  ICMJE
  • Drug: Pregabalin

    drug form : capsule, 75/150mg. Pregabalin will be provided to treatment arm subjects for 6-week Treatment period.

    Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as maintenance + 75mg twice a day as tapering

    Other Name: Brand name of drug : Lyrica
  • Drug: Placebo

    drug form : capsule, 75/150mg. Pregabalin will be provided to treatment arm subjects for 6-week Treatment period.

    Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as maintenance + 75mg twice a day as tapering

Study Arms  ICMJE
  • Active Comparator: Pregabalin

    30 randomly allocated patients after a 4-week run-in period, who will take part in a 6-week treatment period with pregabalin.

    Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as standard dose period + 75mg twice a day for a week as tapering period.

    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo

    30 randomly allocated patients after a 4-week run-in period, who will take part in a 6-week treatment period with placebo.

    Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as standard dose period + 75mg twice a day for a week as tapering period.

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2011)
70
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: (should follow all conditions described below)

  • Etiology : Liver cirrhosis patients of any etiology, whether viral or non-viral
  • Occurrence of muscle cramp equal to or more than 2 times a week over the last month

Exclusion Criteria:

  • Preexisting disease : Occlusive vascular disease, thyroid disease, peripheral neuropathy
  • Drugs within 2 months : Digitalis, cimetidine, clofibrate, lithium, opiate, nifedipine, beta-agonist, beta-blocker, penicillamine, gabapentin, pregabalin, tricyclic anti-depressant, carbamazepine, phenytoin, quinidine, antispastic drugs, verapamil, vitamin E, branched chain amino acid, excessive alcohol consumption (male >40 g/day, female >20 g/day)
  • Underlying disease : Renal impairment (Ccr < 60 mL/min), neuromuscular disease (stroke, cerebral palsy, multiple sclerosis, Parkinson disease, progressive muscular dystrophy, epilepsy), suicidal attack, drug allergy, pregnancy, heart failure
  • Liver status : Serious complications resulting from decompensated cirrhosis except ascites, such as portosystemic encephalopathy, acute variceal bleeding within the past 3 months from study entry
  • central nervous system (CNS) or peripheral nervous system (PNS) or muscular disease, stroke, cerebral palsy, multiple sclerosis, Parkinson disease, progressive muscular dystrophy, epilepsy
  • The previous episode of suicidal attack
  • Drug hypersensitivity
  • Subjects receiving antiepileptic drugs
  • Patients manipulating machines or driving cars
  • Pregnant women
  • Subjects with congestive heart failure requiring medications
  • Galactose-Lactose metabolic abnormality
  • Refractory ascites to medical treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01271660
Other Study ID Numbers  ICMJE 06-2010-132
IG-KOR-014-2010 ( Other Identifier: Pfizer reference number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Won Kim, Seoul National University Boramae Hospital
Study Sponsor  ICMJE Seoul National University Boramae Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Won Kim, Ph.D. SMG-SNU Boramae Medical Center
PRS Account Seoul National University Boramae Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP