Trial | Phase | Enrollment | Study Type | Start Date | Status |
Randomized,2-way Crossover, Bioequivalence Study of Ranitidine 300 mg Tablets Zantac 300 mg Tablets Administered as 1 x 300 mg Tablet in Healthy Subjects Under Fasting Conditions [NCT01131702] | Phase 1 | 24 participants (Actual) | Interventional | 2003-01-31 | Completed |
Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration [NCT04397445] | Phase 1 | 18 participants (Actual) | Interventional | 2020-06-08 | Completed |
The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR) [NCT02123498] | Phase 4 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to IRB not approved) |
The Effect of Concomitant Cimetidine p.o. 400 mg t.i.d. and p.o. Ranitidine 300 mg Once Daily on Single Dose Pharmacokinetics of Tiotropium (14.4 µg) Given Intravenously Over 15 Minutes in Healthy Male and Female Subjects of 50-65 Years (Randomized, Open [NCT02172417] | Phase 1 | 18 participants (Actual) | Interventional | 2000-07-31 | Completed |
A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial [NCT02197143] | Phase 4 | 286 participants (Actual) | Interventional | 2013-03-31 | Completed |
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Subjects [NCT03468777] | Phase 1 | 18 participants (Actual) | Interventional | 2018-03-06 | Terminated(stopped due to The study has been terminated due to pending data analysis) |
A Phase I Open-label, Randomised, Single Dose, Three-way Crossover Relative Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) Formula [NCT02195804] | Phase 1 | 42 participants (Actual) | Interventional | 2009-05-31 | Completed |
Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial. [NCT02170792] | Phase 1 | 30 participants (Actual) | Interventional | 2001-02-28 | Completed |
Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects [NCT01209455] | | 24 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness [NCT00668317] | Phase 3 | 5 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Primary care physicians began prescribing antacid therapy for chronic cough) |
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued [NCT00633672] | Phase 3 | 400 participants (Anticipated) | Interventional | 2001-02-28 | Completed |
Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering Following Subarachnoid Block [NCT02441673] | Phase 2 | 130 participants (Anticipated) | Interventional | 2018-10-12 | Not yet recruiting |
A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg Every Day (qd) Versus Ranitidine 150 mg Twice a Day (Bid) in Patients With an NSAID-associated Gastric Ulcer When Dai [NCT00401752] | Phase 3 | 397 participants (Actual) | Interventional | 2006-03-31 | Completed |
Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (AIRDOC) [NCT00585351] | | 100 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor [NCT05298683] | Phase 2 | 108 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting |
A Randomized Double-Blind Parallel Study of Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD) [NCT00839306] | Phase 3 | 240 participants (Actual) | Interventional | 2008-08-31 | Completed |
Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD) [NCT00838526] | Phase 3 | 240 participants (Actual) | Interventional | 2008-08-31 | Completed |
An Open-Label, 3-Period, Fixed Sequence Study to Evaluate the Effect of an H2 Antagonist and a Proton Pump Inhibitor on the Single Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects [NCT05338502] | Phase 1 | 20 participants (Actual) | Interventional | 2019-07-08 | Completed |
[NCT02733640] | | 42 participants (Actual) | Interventional | 2012-10-31 | Completed |
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects [NCT00930670] | Phase 4 | 320 participants (Actual) | Interventional | 2009-06-30 | Completed |
In Infants With Symptoms of Tracheomalacia or Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms? A Randomized, Controlled Trial [NCT02700087] | | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn |
Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis [NCT02555852] | | 4,238,504 participants (Actual) | Observational | 2011-09-30 | Completed |
Cross-over Trial of Medical Treatment for GERD in Preterm Infants [NCT00131248] | Phase 3 | 18 participants (Actual) | Interventional | 2004-04-30 | Completed |
A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects [NCT01908257] | Phase 1 | 16 participants (Actual) | Interventional | 2013-07-31 | Completed |
Ontogeny of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents [NCT01976078] | | 45 participants (Actual) | Observational | 2012-09-30 | Completed |
Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial [NCT02004197] | Phase 2/Phase 3 | 176 participants (Actual) | Interventional | 2010-01-31 | Completed |
Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study. [NCT00590928] | Phase 4 | 75 participants (Actual) | Interventional | 2004-07-31 | Completed |
An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone in Fed and Fasted State and in Combination With Ranitidine in Fasted State, and to Assess the [NCT01682408] | Phase 1 | 28 participants (Actual) | Interventional | 2012-09-30 | Completed |
A Phase 2 Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain [NCT01332630] | Phase 2 | 24 participants (Actual) | Interventional | 2011-08-16 | Completed |
[NCT00633412] | Phase 3 | 400 participants (Anticipated) | Interventional | 2001-02-28 | Completed |
A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study [NCT00702871] | Phase 4 | 50 participants (Actual) | Interventional | 2005-03-31 | Completed |
A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects [NCT01392755] | Phase 1 | 32 participants (Actual) | Interventional | 2011-07-31 | Completed |
A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions [NCT00405119] | Phase 2 | 92 participants (Actual) | Interventional | 2006-05-31 | Completed |
Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes [NCT02953210] | Phase 4 | 40 participants (Anticipated) | Interventional | 2016-11-30 | Enrolling by invitation |
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3 [NCT00002106] | Phase 2 | 104 participants | Interventional | | Completed |
Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin [NCT01287520] | Phase 1 | 41 participants (Actual) | Interventional | 2007-11-30 | Completed |
Pharmacokinetic Interaction Between Trospium Chloride After Intravenous (2 mg) and Oral Administration (30 mg) With Ranitidine (300 mg p.o.) as an Inhibitor of OCT1 and With Clarithromycin (500 mg p.o.) as an Inhibitor of P-glycoprotein in 24 Healthy Subj [NCT03011463] | Phase 1 | 24 participants (Actual) | Interventional | 2016-11-30 | Completed |
YF476: Effects of a Single Dose at 3 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Ranitidine in Healthy Volunteers [NCT01538797] | Phase 1 | 22 participants (Actual) | Interventional | 1996-07-31 | Completed |
A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects When a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination With Omeprazole or Ranitidine [NCT01539655] | Phase 1 | 34 participants (Actual) | Interventional | 2012-02-29 | Completed |
Studies of Esophageal Metaplasia Using a Novel Antibody: Reversibility of Columnar Metaplasia by Proton Pump Inhibitor [NCT00161200] | Phase 3 | 60 participants | Interventional | 2002-12-31 | Terminated(stopped due to slow accrual) |
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL) [NCT02999633] | Phase 2 | 14 participants (Actual) | Interventional | 2017-03-08 | Terminated(stopped due to Due to an unsatisfactory benefit/risk ratio, as specified in & 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely) |
A Prospective, Randomized Trial Comparing the Effect of Intravenous Omeprazole to That of Intravenous Ranitidine on the Maintenance of Hemostasis After Successful Endoscopic Treatment of Bleeding Peptic Ulcer [NCT00247130] | Phase 4 | 0 participants (Actual) | Interventional | 2005-10-31 | Withdrawn(stopped due to Superiority of iv omeprazole to ranitidine has already been proven by others.) |
Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study) [NCT00247715] | | 664 participants (Actual) | Interventional | 2003-10-31 | Completed |
Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial. [NCT01737840] | Phase 4 | 66 participants (Actual) | Interventional | 2012-10-31 | Completed |
The Effect of Increasing Gastric pH Upon the Bioavailability of Orally Administered Phosphonoformic Acid (Foscarnet) [NCT00000964] | Phase 1 | 6 participants | Interventional | | Completed |
A Phase II Clinical Trial of BMS-247550 (NSC 710428), an Epothilone B Analog, in Renal Cell Carcinoma [NCT00030992] | Phase 2 | 102 participants (Actual) | Interventional | 2002-02-28 | Completed |
Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study [NCT03140033] | Phase 2 | 158 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
A Double-Blind, Randomized, Placebo-Controlled Cross-Over Study Assessing the Role of Pathogen-Specific IgE and Histamine Release in the Hyper-IgE Syndrome and the Effect of Ranitidine on Laboratory and Clinical Manifestations [NCT00527878] | Phase 2 | 16 participants (Actual) | Interventional | 2007-09-30 | Terminated(stopped due to Failure to enroll adequate patient numbers due to small number of eligible patients) |
Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study [NCT01896557] | Phase 4 | 92 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass [NCT03583567] | Phase 4 | 40 participants (Actual) | Interventional | 2018-09-05 | Completed |
Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity [NCT03145012] | Phase 4 | 30 participants (Actual) | Interventional | 2018-05-01 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00030992)
Timeframe: 10 years
Intervention | Participants (Number) |
---|
BMS-247550 | 99 |
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Response Rate
Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00030992)
Timeframe: 6 weeks
Intervention | Percentage of participants (Number) |
---|
| Complete response | Partial Response | Progressive disease | Stable disease |
---|
BMS-247550 | 1 | 9.4 | 12.6 | 76.8 |
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Bradycardia Episodes/Day
(NCT00131248)
Timeframe: 7 days
Intervention | episodes per day (Mean) |
---|
Medications | 4.6 |
Placebo | 3.6 |
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The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.
"Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.~(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent)." (NCT00401752)
Timeframe: 4 weeks
Intervention | Percentage of participants (Number) |
---|
Esomeprazole | 59.4 |
Ranitidine | 59.5 |
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Percentage of Participants With the Occurance of Any Adverse Event.
Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment. (NCT00401752)
Timeframe: 8 weeks
Intervention | Percentage of participants (Number) |
---|
Esomeprazole | 16.8 |
Ranitidine | 22.7 |
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The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment. (NCT00401752)
Timeframe: 4 and 8 week
Intervention | Percentage of participants (Number) |
---|
Esomeprazole | 93.3 |
Ranitidine | 81.8 |
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The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy
Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment. (NCT00401752)
Timeframe: 4 & 8 weeks
Intervention | Percentage of participants (Number) |
---|
Esomeprazole | 80.2 |
Ranitidine | 69.4 |
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The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment. (NCT00401752)
Timeframe: 8 weeks
Intervention | Percentage of participants (Number) |
---|
Esomeprazole | 81.1 |
Ranitidine | 73.9 |
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The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8. (NCT00401752)
Timeframe: week 4 and week 8
Intervention | Percentage of participants (Number) |
---|
Esomeprazole | 100 |
Ranitidine | 97.7 |
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New Skin Infections
Patients reported the number of new skin infections (NCT00527878)
Timeframe: 12 months placebo/12 months ranitidine
Intervention | skin infections (Median) |
---|
Placebo | 1 |
Ranitidine | 0 |
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Clinical Severity Score
Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe. (NCT00527878)
Timeframe: one year on ranitidine and one year on placebo
Intervention | score on a scale (Mean) |
---|
Placebo | 9.8 |
Ranitidine | 8.5 |
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New Lung Infections
Number of new infection while on placebo or study drug (NCT00527878)
Timeframe: 12 months placebo and 12 months ranitidine
Intervention | new lung infections (Median) |
---|
Placebo | 1 |
Ranitidine | 0 |
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Number of Infections in Subjects With HIES.
Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage). (NCT00527878)
Timeframe: 1 year on intervention
Intervention | infections (Median) |
---|
Placebo | 4 |
Ranitidine | 4 |
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Prevention of Chemical Pneumonitis
Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo). (NCT00585351)
Timeframe: Assessed on the day of discharge (average length of stay is approximately 3-7 days)
Intervention | Participants (Number) |
---|
Advanced Notification + Ranitidine | 5 |
No Advanced Notification + Ranitidine | 7 |
Advanced Notification + Placebo | 6 |
No Advanced Notification + Placebo | 3 |
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Change in Methacholine Sensitivity
"Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).~To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine" (NCT00668317)
Timeframe: baseline and 8 weeks
Intervention | mg/ml (Mean) |
---|
Omeprazole and Ranitidine | 0.598 |
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Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference. (NCT00838526)
Timeframe: Baseline to Week 26
Intervention | Percentage of Participants (Number) |
---|
RAN 150mg BID | 32.9 |
RAB ER 50mg QD | 84.9 |
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Percentage of Participants With Adverse Events by Category
An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product. A treatment emergent AE (TEAE) was any AE beginning on or after the confirmed date of first dose of study medication, up to and including 7 days after the last dose of study medication. A TEAE was considered related to study treatment if a causal relationship between the study treatment and the AE was a reasonable possibility. AEs were graded as severe if they were incapacitating, with inability to work or to perform normal daily activity. Serious AEs (SAEs) were events that resulted in death, were life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or were a congenital anomaly/birth defect. (NCT00838526)
Timeframe: From the time of administration of the first dose of study drug up to a maximum of approximately 30 weeks.
Intervention | Percentage of participants (Number) |
---|
| Any TEAE | Treatment-related TEAE | Severe TEAE | Severe, treatment-related TEAE | Death | Other SAE | Treatment-related SAE | TEAEs leading to discontinuation of treatment |
---|
RAB ER 50mg QD | 64.2 | 14.5 | 8.1 | 0.6 | 0 | 6.4 | 0 | 6.9 |
,RAN 150mg BID | 47.5 | 8.5 | 3.4 | 1.7 | 0 | 1.7 | 0 | 6.8 |
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Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities). (NCT00838526)
Timeframe: Baseline to Week 26
Intervention | Percentage of Participants (Number) |
---|
| Yes | No | Missing |
---|
RAB ER 50mg QD | 57.4 | 18.8 | 23.9 |
,RAN 150mg BID | 8.5 | 25.4 | 66.1 |
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Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference." (NCT00839306)
Timeframe: Baseline to Week 26
Intervention | Percentage of Participants (Number) |
---|
RAN 150mg BID | 31.7 |
RAB ER 50mg QD | 88.4 |
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Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities). (NCT00839306)
Timeframe: Baseline to Week 26
Intervention | Percentage of Participants (Number) |
---|
| Yes | No | Missing |
---|
RAB ER 50mg QD | 53.7 | 17.5 | 28.8 |
,RAN 150mg BID | 8.3 | 16.7 | 75 |
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PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314
(NCT01287520)
Timeframe: Cycle 1 Day 1 of a 28-day cycle
Intervention | nanograms per milliliter (Geometric Mean) |
---|
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2) | 122 |
LY 20/Carb 6/Pem 500 (Cohort 3) | 246 |
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9 ) | 603 |
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7 | 898 |
LY 120/Carb 6/Pem 500 (Cohort 6) | 1700 |
LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 881 |
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PK Parameter: Cmax of Free Carboplatin
Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle
Intervention | nanograms/milliliter/milligram (Geometric Mean) |
---|
Carboplatin (Doublet Therapy) | 24.0 |
Carboplatin (Triplet Therapy) | 25.5 |
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PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb. (NCT01287520)
Timeframe: Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle
Intervention | nanograms*hour per milliliter (Geometric Mean) |
---|
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2) | 192 |
LY 20/Carb 6/Pem 500 (Cohort 3) | 404 |
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9) | 938 |
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7) | 1830 |
LY 120/Carb 6/Pem 500 (Cohort 6) | 2190 |
LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 1570 |
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PK Parameter: AUC0-∞ of Free Carboplatin (Carb)
AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle
Intervention | hours*nanograms per milliliter per mg (Geometric Mean) |
---|
Carboplatin (Doublet Therapy) | 81.6 |
Carboplatin (Triplet Therapy) | 88.1 |
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Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314
AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone. (NCT01287520)
Timeframe: Cycle 1 Day 1 of a 28 day cycle
Intervention | nanograms*hour per milliliter (Geometric Mean) |
---|
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2) | 216 |
LY 20/Carb 6/Pem 500 (Cohort 3) | 427 |
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9) | 976 |
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7) | 1870 |
LY 120/Carb 6/Pem 500 (Cohort 6) | 3310 |
LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 1600 |
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Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)
AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle
Intervention | hours*nanograms/milliliter/ milligram (Geometric Mean) |
---|
Pemetrexed (Doublet Therapy) | 212 |
Pemetrexed (Triplet Therapy) | 202 |
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PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
(NCT01287520)
Timeframe: Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle
Intervention | nanograms per milliliter (Geometric Mean) |
---|
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2) | 106 |
LY 20/Carb 6/Pem 500 (Cohort 3) | 271 |
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9) | 657 |
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7) | 1150 |
LY 120/Carb 6/Pem 500 (Cohort 6) | 768 |
LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 1040 |
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PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)
Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle
Intervention | nanogram per milliliter per milligram (Geometric Mean) |
---|
Pemetrexed (Doublet Therapy) | 109 |
Pemetrexed (Triplet Therapy) | 108 |
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Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD])
Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of >5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval. (NCT01287520)
Timeframe: Baseline up to Day 28 (Cycle 1)
Intervention | milligrams (mg) (Number) |
---|
LY2090314/Pemetrexed/Carboplatin | 40 |
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Number of Participants With Best Overall Tumor Response
Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. (NCT01287520)
Timeframe: Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)
Intervention | participants (Number) |
---|
| CR | PR | SD | PD | Unknown (discontinued before response assessment) |
---|
LY 10/Carb 5/Pem 500 (Cohort 1) | 0 | 0 | 2 | 0 | 1 |
,LY 10/Carb 6/Pem 500 (Cohort 2) | 0 | 0 | 4 | 2 | 1 |
,LY 120/Carb 6/Pem 500 (Cohort 6) | 0 | 0 | 0 | 0 | 0 |
,LY 20/Carb 6/Pem 500 (Cohort 3) | 0 | 1 | 2 | 1 | 1 |
,LY 40/Carb 6/Pem 500 (Cohort 4) | 0 | 1 | 2 | 3 | 0 |
,LY 40/Carb 6/Pem 500 + R50 (Cohort 9) | 0 | 0 | 2 | 2 | 1 |
,LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 0 | 1 | 1 | 2 | 0 |
,LY 80/Carb 6/Pem 500 (Cohort 5) | 0 | 0 | 0 | 1 | 2 |
,LY 80/Carb 6/Pem 500 + R50 (Cohort 7) | 0 | 1 | 1 | 0 | 0 |
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Overall Response Rate (ORR)
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01332630)
Timeframe: 8-24 weeks
Intervention | Participants (Count of Participants) |
---|
TPI 287 | 21 |
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Visual Analogue Scale Score
The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain. (NCT01737840)
Timeframe: 30th and 60th minutes
Intervention | Visual Analogue Scale (Mean) |
---|
| VAS score changes at 60 minutes | VAS scores changes at 30 minutes |
---|
Pantoprazole | 39.6 | 27.6 |
,Ranitidine | 42.3 | 28.3 |
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Need for Additional Drug
The investigators are measuring the need for additional drug at the end of 60 minutes. (NCT01737840)
Timeframe: 60 th minute
Intervention | participants (Number) |
---|
Pantoprazole | 13 |
Ranitidine | 8 |
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Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment
One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units. (NCT01896557)
Timeframe: One week after randomized treatment exposure (omeprazole or ranitidine)
Intervention | P2Y12 Reactivity Units (Mean) |
---|
Omeprazole | 173.54 |
Ranitidine | 153.61 |
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Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.
One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as the percent change in aggregability from baseline, with the formula IPA = (on-treatment aggregability minus baseline aggregability)/baseline aggregability. Since baseline aggregation is always, per definition, equal or more than on-treatment aggregation, there is no possibility that this number might be negative. (NCT01896557)
Timeframe: One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline
Intervention | Percentage (Mean) |
---|
Omeprazole | 17.4 |
Ranitidine | 30.1 |
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Comparison of the Primary Outcome With Bioimpedance Aggregometry
After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: bioimpedance aggregometry with ADP 10 mcM as reagent (NCT01896557)
Timeframe: 1 week after drug exposure
Intervention | Ohms (Mean) |
---|
Omeprazole | 2 |
Ranitidine | 2.77 |
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Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)
After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: PFA-100(Collagen/ADP cartridge). (NCT01896557)
Timeframe: 1 week after drug exposure
Intervention | seconds (Mean) |
---|
Omeprazole | 95.1 |
Ranitidine | 97.2 |
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Percentage of Participants With Objective Response
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC. (NCT02999633)
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)
Intervention | percentage of participants (Number) |
---|
Isatuximab | 0 |
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Cumulative Ranitidine Amount Excreted in Urine Over 24 Hours After Drug Administration
The cumulative amount of ranitidine excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.
Intervention | milligrams (Geometric Mean) |
---|
Ranitidine and Cured Meats Diet | 91.7 |
Ranitidine and Noncured Meats Diet | 74.1 |
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Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Ranitidine and Placebo)
The cumulative amount of NDMA excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.
Intervention | nanograms (Median) |
---|
Ranitidine and Noncured Meats Diet | 0.6 |
Placebo and Noncured Meats Diet | 10.5 |
Ranitidine and Cured Meats Diet | 11.9 |
Placebo and Cured Meats Diet | 23.4 |
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Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Diets)
The cumulative amount of NDMA excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.
Intervention | nanograms (Median) |
---|
Ranitidine and Cured Meats Diet | 11.9 |
Ranitidine and Noncured Meats Diet | 0.6 |
Placebo and Cured Meats Diet | 23.4 |
Placebo and Noncured Meats Diet | 10.5 |
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Cumulative Dimethylamine (DMA) Amount Excreted in Urine Over 24 Hours After Drug Administration
The cumulative amount of DMA excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.
Intervention | milligrams (Geometric Mean) |
---|
Ranitidine and Noncured Meats Diet | 38.8 |
Placebo and Noncured Meats Diet | 41.1 |
Ranitidine and Cured Meats Diet | 40.7 |
Placebo and Cured Meats Diet | 43.1 |
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AUC(0-t) of Plasma DMA
Determined for each subject using non-compartmental methods. All parameters will be reported with standard descriptive statistics including the geometric mean and coefficient of variation. Calculation of pharmacokinetic parameters will be performed using actual sampling times over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose with planned samples at 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 11, 14, and 24 h post-dose
Intervention | micrograms*hour/milliliter (Geometric Mean) |
---|
Ranitidine and Noncured Meats Diet | 26.3 |
Placebo and Noncured Meats Diet | 26.2 |
Ranitidine and Cured Meats Diet | 20.9 |
Placebo and Cured Meats Diet | 20.9 |
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AUC(0-t) of Plasma Ranitidine
Determined for each subject using non-compartmental methods. All parameters will be reported with standard descriptive statistics including the geometric mean and coefficient of variation. Calculation of pharmacokinetic parameters will be performed using actual sampling times over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose with planned samples at 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 11, 14, and 24 h post-dose
Intervention | nanograms*hour/milliliter (Geometric Mean) |
---|
Ranitidine and Cured Meats Diet | 3736 |
Ranitidine and Noncured Meats Diet | 4857 |
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