AN OPEN-LABEL, EXTENSION SAFETY TRIAL OF PREGABALIN IN SUBJECTS WITH NEUROPATHIC PAIN ASSOCIATED WITH HIV NEUROPATHY (PREGABALIN A0081251)

PFIZER S.A.,0 个研究点目标入组 0 人开始时间: 2011年2月21日最近更新: 2023年9月4日

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•1. EVIDENCE OF A PERSONALLY SIGNED AND DATED INFORMED CONSENT DOCUMENT INDICATING THAT THE SUBJECT HAS BEEN INFORMED OF ALL PERTINENT ASPECTS OF THE STUDY.
•2. SUBJECTS WHO ARE WILLING AND ABLE TO COMPLY WITH SCHEDULED VISITS, TREATMENT PLAN, LABORATORY TESTS, AND OTHER STUDY PROCEDURES.
•3. SUBJECTS WHO PARTICIPATED IN THE PRECEDING A0081244 DOUBLE-BLIND TRIAL AND COMPLETED AT LEAST THROUGH VISIT 9 OF THAT TRIAL.
•4. SUBJECTS WITH PAINFUL DSP INTERESTED IN TREATMENT BASED ON INVESTIGATOR´S CLINICAL JUDGMENT.
•5. SUBJECTS WHO HAD ACCEPTABLE TOLERABILITY OF STUDY DRUG IN A0081244.
•6. MALE AND NON-PREGNANT, NON-LACTATING, POSTMENOPAUSAL, OR SURGICALLY STERILIZED FEMALE SUBJECTS AT LEAST 18 YEARS OF AGE, OF ANY ETHNIC ORIGIN; WOMEN OF CHILDBEARING POTENTIAL MUST USE APPROPRIATE METHODS OF CONTRACEPTION (INCLUDING BARRIER 01 HORMONAL METHOD; ABSTINENCE MAY BE CONSIDERED IN SUBJECTS FOR WHOM THE INVESTIGATOR DEEMS THIS METHOD IS RELIABLE); ALL WOMEN MUST HAVE A CONFIRMED NEGATIVE URINE PREGNANCY TEST PRIOR TO ENROLLMENT.
•7. LIFE EXPECTANCY OF 12 MONTHS.

•1. CLINICALLY SIGNIFICANT OR UNSTABLE CONDITIONS THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD COMPROMISE PARTICIPATION IN THE STUDY. THIS INCLUDES, FOR EXAMPLE, MEDICAL CONDITIONS SUCH AS, BUT NOT LIMITED TO: HEPATIC, RENAL, RESPIRATORY, HEMATOLOGICAL, IRNMUNOLOGICAL, CARDIOVASCULAR DISEASES, ARRHYTHMIA, INFLAMMATORY OR RHEUMATOLOGIC DISEASE, ACTIVE INFECTIONS, SYMPTOMATIC PERIPHERAL VASCULAR DISEASE, PSYCHIATRIC ILLNESS, AND UNTREATED ENDOCRINE DISORDERS.
•2. OTHER SEVERE ACUTE OR CHRONIC MEDICAL OR PSYCHIATRIC CONDITION OR LABORATORY ABNORMALITY THAT MAY INCREASE THE RISK ASSOCIATED WITH STUDY PARTICIPATION OR INVESTIGATIONAL PRODUCT ADMINISTRATION OR MAY INTERFERE WITH THE INTERPRETATION OF STUDY RESULTS AND, IN THE JUDGMENT OF THE INVESTIGATOR, WOULD MAKE THE SUBJECT INAPPROPRIATE FOR ENTRY INTO THIS STUDY.
•3. ACTIVE ACQUIRED IMMUNE DEFICIENCY SYNDROME (ALDS)- DEFINING OPPORTUNISTIC INFECTION (01) THAT REQUIRES HOSPITALIZATION.
•4. RISK OF SELF HARM BASED ON SCREENING CRITERIA S-STS AND PHQ~8 (SEE SECTION 7.2.4.1).
•5. CONCURRENT PARTICIPATION IN ANOTHER C1INICAL TRIAL, WITH THE EXCEPTION OF OBSERVATIONAL TRIALS,
•6. CURRENTLY HAS ACTIVE MALIGNANT DISEASE, MALIGNANCIES IN REMISSION THAT DO NOT REQUIRE FURTHER TREATMENT OR KAPOSI´S SARCOMA REQUIRING LOCAL TREATMENT ONLY ARE ALLOWED,

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