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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 August 2016 |
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Main ID: |
NCT02868801 |
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Date of registration:
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08/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
EASOPSRTFP |
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Scientific title:
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Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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280 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02868801 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Liang Yunsheng, M.D. |
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Address:
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Telephone:
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UN |
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Email:
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liangyunsheng@hotmail.com |
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Affiliation:
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Name:
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Lu Qianjin, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Central South University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Outpatient ,Patients can not stay in the hospital overnight;
2. Patients must have pain present for more than 3 months after the healing of the
herpes zoster skin rash;
3. At least 4 days and at least 8 pain diaries(Pain Numeric Rating Scale) must be
completed satisfactorily within the seven days of single-blind, placebo run-in
period, and the average pain score must be greater than or equal to 4;
4. At screening (V0) and enrollment (V1), patients must have a score of greater than or
equal to 40 mm on the 100 mm pain visual analog scale;
5. Women were neither pregnant nor lactating, and those of childbearing age had a
confirmed negative serum pregnancy test at baseline and practiced an appropriate
method of contraception throughout the study.
Exclusion Criteria:
1. Decrease of =30% on their pain VAS or = 4 between any two pain diaries during the
placebo run-in period.( in order to remove potential placebo-responders);
2. Patients who had failed to respond to previous treatment for PHN with gabapentin at
doses =1200 mg/day ;
3. History of using pregabalin or participation in a previous trial of pregabalin;
4. Patients with a skin condition or severe non-PHN pain that might impair the self
assessment of pain caused by PHN;
5. Patients with other Nervous system disorders which might impair completing the pain
diaries or sleep interference diaries;
6. History of epilepsy and being treated by drug therapy;
7. Previous surgical therapy for PHN;
8. History of using effective therapies during 2 weeks before screening (V0),eg:
acupuncture and moxibustion, Transcutaneous Electrical Nerve Stimulation;
9. Potentially retinal toxicity of drugs past or now;
10. Prohibited medications without appropriate washout;
11. Malignancy within the past 2 years;
12. Laboratory examination: WBC<2.5×109/L;ANC<1.5×109/L;PLT<100×109/L;ALT/AST>3ULN;
13. Creatinine clearance = 60 mL/min;
14. Positive antibody of Hepatitis c,Human immunodeficiency virus ,Treponema pallidum ;
15. Patients who are allergic to or intolerant of pregabalin or other drugs which have a
similarly chemical structure ;
16. History of illicit drug or alcohol abuse within the last 2 years;
17. Clinically significant or unstable hepatic, respiratory, or hematologic illnesses or
psychologic conditions; unstable cardiovascular disease which may increase the risk
of participation the clinical trial in the opinion of the study investigator.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postherpetic Neuralgia
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Intervention(s)
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Drug: Pregabalin SR tablet 330mg/day
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Drug: Pregabalin SR tablet 165mg/day
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Drug: Placebo
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Drug: Pregabalin SR tablet 660mg/day
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Primary Outcome(s)
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Number of Responders
[Time Frame: 15 weeks]
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Secondary Outcome(s)
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50% reduction in weekly mean pain score from baseline to study completion
[Time Frame: 15 weeks]
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Change of Mean Sleep Interference Scores from study completion to baseline
[Time Frame: 15 weeks]
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Change of Mean Pain Scores from study completion to baseline
[Time Frame: 15 weeks]
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Secondary ID(s)
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HRPRBL-PHN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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