EUCTR2007-001487-67-DE进行中（未招募）不适用
A PARALLEL-GROUP, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER DOSE RESPONSE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF- 00885706, A 5-HT4 RECEPTOR PARTIAL AGONIST, AS ADD-ON THERAPY TO ESOMEPRAZOLE FOR THE RELIEF OF SYMPTOMS IN SUBJECTS WITH GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) WHO HAVE A POOR RESPONSE TO PROTON PUMP INHIBITOR (PPI) TREATMENT
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK0 个研究点目标入组 450 人开始时间: 2007年9月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •2. Subjects with a diagnosis of GERD who fulfill the following criteria
- •who have symptoms for at least six months prior to enrolment
- •who are currently prescribed daily treatment with a PPI and have been on such treatment for at least 3 months
- •whose symptoms are persistent(1), troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI
- •who are seeking relief of persistent symptoms
- •(1) persistent symptoms: Minimum of 4 days (in a week) with at least mild symptoms (i.e. symptom does not last long and is easily tolerated) or minimum of 2 days with moderate (i.e. symptom causes discomfort and interrupts usual activities including sleep) to severe symptoms (i.e. symptom causes great interference with usual activities [including sleep] and may be incapacitating.
- •3. Male or female subject aged 18 to 65 years inclusive.
- •4. All female subjects must fulfill adequate contraception criteria
- •A negative serum or urine pregnancy test within 72 hours prior to start of study medication for Women of Child Bearing Potential (WOCBP*). WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal**. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
- •* Female subjects of non-childbearing potential must meet at least one of the following criteria:
- •- **Postmenopausal females, defined as:
- •Females over the age of 60 years.
- •Females who are 45 to 60 years of age must be amenorrheic for at least 2 years PLUS have a serum FSH level within the laboratory’s reference range for postmenopausal women.
- •- Females who are permanently sterilized (e. g. hysterectomy, bilateral oophorectomy and tubal ligation).
- •All other female subjects will be considered to be of childbearing potential and willing to utilize an acceptable form of contraception*** from screening to at least a month after the study.
- •*** Acceptable contraceptive method for female subjects of childbearing potential include one of the following: Female subjects who wish to use nonhormonal contraception must have done so for at least 14 days prior to the first dose of study medication.
- •Combined oral contraceptive pill
- •Hormonal methods of contraception (including injectable [e.g Depo-Provera, Lunelle], implants [e.g. Norplant]) at least 14 days prior to the first dose of study medication;
- •Placement of a copper-containing intrauterine device (IUD);
- •Male partner who has had a vasectomy for at least 4 months
- •5. Body Mass Index (BMI) of 18 to 40 kg/m2
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects not able or unwilling to provide informed consent and or to follow study
- •procedures or considered to be non compliant according to the investigator
- •2. Subjects with any of the following diseases/conditions which, in the opinion of the investigator, may be the cause of or may contribute significantly to symptoms associated with GERD):
- •a. Zollinger-Ellison syndrome
- •b. Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm or nutcracker esophagus.
- •c. Esophageal disorders such as strictures and Barrett’s esophagus,
- •d. Surgical or endoscopic treatment for GERD, e.g. fundoplication, gastrectomy, history or presence of esophageal or gastric neoplasms
- •e. History of esophageal, gastric or duodenal surgery, except for simple closure of
- •f. Active gastric or duodenal ulcers
- •g. Malabsorption or Inflammatory Bowel Disease
- •h. Irritable Bowel Syndrome
- •i.Hiatus hernia
- •3. Subjects diagnosed with erosive esophagitis (subjects must have had an endoscopy within the last 5 years to verify absence or alarm symptoms such as dysphagia (difficulty swallowing); odynophagia (painful swallowing); gastrointestinal bleeding or anemia; weight loss; and chest pain.
- •4. If female; pregnant, lactating or positive serum or urine pregnancy tests.
- •5. Subjects presenting with any of the following will not be included in the study:
- •Cardiovascular
- •a. Subjects with a history of cardiovascular disease, e.g. ischemic heart disease, arrhythmias, QT prolongation (QTcF > 450msec), myocardial infarction or stroke
- •b. Subjects with uncontrolled hypertension (BP > 140/90 mm of Hg) or a history of
- •symptomatic hypotension at screening
- •c. Subjects with a significant history of symptomatic postural hypotension or
- •greater than a 20mmHg drop in systolic or 10 mmHg drop in diastolic blood
- •pressure on standing at screening
- •d. Subjects with a screening 12-lead ECG demonstrating any clinically
- •significant abnormality including QT prolongation (QTcF > 450 msec)
- •e. Subjects on beta adrenoceptor blocking drugs
- •Renal impairment (creatinine > 1.5 x ULN and/or estimated creatinine clearance = 50 ml/min using Cockcroft-Gault equation)
- •Alanine aminotransferase (ALT) =2 times the upper limit of normal (ULN) at screening (Visit 1) as defined by the central laboratory;
- •Subjects with a history of malignancy who have not been in remission for at least 5
- •years at the time of the baseline visit.
- •Note for clarification: Subjects with basal and squamous cell carcinomas are eligible
- •for entry within the 5 year period provided they have been disease-free for 12 months at the time of entry, and they are followed up regularly by a dermatologist
- •Uncontrolled diabetes mellitus (HbA1c > 7). Stable diabetes controlled by diet, oral
- •agents or insulin is acceptable
- •History of ethanol abuse, substance abuse, or social situations that may affect
- •adherence to the study protocol
- •Subjects with a positive Hepatitis B, Hepatitis C or HIV test.
- •6. Subjects who have received any investigational drug or device within 30 days of
- •screening, or who is scheduled to receive another investigational drug or device in the course of the study.
- •7. Subjects who are unable or unwilling to withdraw from prescribed proton pump
- •inhibitors and replace with standard study PPI treatment (Esomeprazole 20 mg).
- •8. Subjects who are unable or unwilling to stop gastro-prokinetic or other drugs for the treatment of GERD for the duration of the study (eg H2RAs, metoclopramide)
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