Phase 4 N=178 A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Peptic Ulcer
Primary: Number of Participants in Whom Peptic Ulcer Was Healed — 66; 66 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=427 Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
Prevention
Primary: Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. — 1; 16; 1; 4 Participants — p=<0.001
Phase 3 N=519 Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Gastric Ulcer
Primary: Number of Participants With Gastric Ulcer Confirmed by Endoscopy — 7; 22 participants — p=0.005
Phase 3 N=530 A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Gastric Ulcer
Primary: Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg — 10; 23 participants — p=0.020
N/A N=3,366 Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
Gastric or Duodenal Ulcers
Primary: Frequency of Adverse Drug Reactions — 1; 1; 1; 1 participants
Phase 3 N=2,426 Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
Gastric Ulcer · Duodenal Ulcer
Primary: Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). — 1.35; 1; 6.58 percentage of participants
Phase 3 N=471 Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Primary: Cumulative Recurrent Rates of Gastric or Duodenal Ulcers — 2.8; 1.4; 21.7 Events/100 participants/24 weeks — p=<0.001
Phase 3 N=366 Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
Stomach Ulcer · Duodenal Ulcer
Primary: Number of Participants With Gastric Ulcer and/or Duodenal Ulcer — 15; 46 participants — p=<0.0001
Phase 3 N=405 Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Primary: Percentage of Participants With Treatment Emergent Adverse Events (AEs) — 77.1; 83.8 Percentage of participants
Phase 2 N=247 Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Gastroduodenal Ulceration
Primary: Incidence of Gastroduodenal Ulcers — 28; 34 participants
Phase 2 N=165 Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
Peptic Ulcer
Primary: Recurrent Peptic Ulcer — 1; 9 participants
Phase 2 N=204 Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Upper Gastrointestinal Mucosal Damage
Primary: Incidence of Subjects With Gastroduodenal Erosions and Ulcers. — 72; 54; 19; 36 participants
N/A N=1,119 Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Gastric or Duodenal Ulcers
Primary: Percentage of Participants Who Had One or More Adverse Drug Reactions — 1.79 Percentage of Participants
N/A N=228 Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer
Peptic Ulcer
Primary: Number of Participants With Healed Peptic Ulcer — 106; 101 participants
Phase 3 N=251 Low Dose Aspirin for Venous Leg Ulcers
Venous Leg Ulcer
Primary: Time to Complete Healing of Reference Ulcer — 77; 69 days — p=0.246
Phase 3 N=343 Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
Gastric Ulcer · Duodenal Ulcer · Rheumatoid Arthritis
Primary: Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period — 167; 112 Participants
Phase 3 N=380 Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
Aspirin-Associated Gastric Ulcers
Primary: Number of Subjects Monitored for Long-term Safety of PA32540 — 379 participants
N/A N=3,502 Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs
Gastric or Duodenal Ulcers
Primary: Frequency of Adverse Drug Reactions — 1; 1; 1; 1 participants
Phase 3 N=219 Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
Gastric Ulcer
Primary: 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…
N/A N=9 Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Aspirin Blood Level · Proton Pump Inhiditor Treatment
Primary: Aspirin Level in Blood (Area Under the Curve) — 49.4; 50.7; 8.7; 6.5 mg*hour/mL
N/A N=101 Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers
Peptic Ulcer
Primary: Number of Participants With Ulcer Recurrence — 1; 7 participants
Phase 3 N=130 Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Gastric Ulcer · Duodenal Ulcer · Rheumatoid Arthritis
Primary: Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period — 125 Participants
Phase 2 N=122 Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus
Barrett Esophagus · Esophageal Cancer
Primary: Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples — -67.6; -123.9; -174.9 pg/mL — p=0.0955
Phase 3 N=627 Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
Peptic Ulcer
Primary: Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. — 40; 38 participants — p=0.0018
Phase 1 N=102 Naproxen Sodium/ASA Platelet Study
Hematology
Primary: Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration — 93.09; 87.71; 92.87; 98.72 percentage
Phase 1 N=24 Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo
Gastrointestinal Lesions
Primary: Endoscopic Score - Cryer Score — 4; 4 Cryer score
Phase 3 N=400 Low Doses of Aspirin in the Prevention of Preeclampsia
Preeclampsia
Primary: Incidence of Preterm (<37 Weeks) Preeclampsia — 22; 16 Participants — p=0.28
Phase 4 N=40 Ulcer Prevention Study in Post Gastric Bypass Patients
Marginal Ulcers
Primary: Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. — 17; 13 participants
Phase 4 N=28 Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Gastrointestinal Mucosal Damage
Primary: Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule — 0.33; 1.48 Scores on a scale — p=<0.0001
Phase 4 N=36 Aspirin Dosing in Diabetic Patients
Type 2 Diabetes Mellitus · Coronary Artery Disease
Primary: Collagen Induced Aggregation — 32 percentage of platelet aggregation