scholarly journals Mucosal Healing Effectiveness and Safety of Anaprazole, a Novel PPI, vs. Rabeprazole in Patients With Duodenal Ulcers: A Randomized Double-Blinded Multicenter Phase II Clinical Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Xu Shu ◽  
Zhenhua Zhu ◽  
Yu Fu ◽  
Zhenyu Zhang ◽  
Jiangbin Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Ulcer Healing ◽  
Safety Profile ◽  
Healing Rate ◽  
Mucosal Healing ◽  
Duodenal Ulcers ◽  
Rate Difference ◽  
Ulcer Healing Rate ◽  
Double Blinded

Background: Proton pump inhibitors (PPIs) are validated gastric acid suppressors and have been widely used to treat patients with active duodenal ulcers. Although existing PPIs have shown great efficacy, many scientists are still devoted to developing more effective PPIs with better safety profile. Herein, we aimed to compare the safety and efficacy of anaprazole in duodenal mucosal healing, a novel PPI, to that of rabeprazole.Methods: In this multicenter, randomized, positive-controlled, double-blinded, parallel-group phase II clinical trial, a total of 150 qualified patients with endoscopically confirmed active duodenal ulcers were randomized (1:1:1) to receive rabeprazole 10 mg, anaprazole 20 mg or anaprazole 40 mg for 4 weeks. The ulcer healing rates after 4 weeks of treatment were compared between groups by independent central review and investigator review. In addition, symptoms and safety were evaluated.Results: Based on the independent central review, the ulcer healing rates of the 10 mg rabeprazole, 20 mg anaprazole and 40 mg anaprazole groups were 88.0, 85.1, and 87.5%, respectively, in the FAS population and 88.9, 86.0, and 90.9%, respectively, in the PPS population. The ulcer healing rate difference between anaprazole 20 mg and Rabeprazole 10 mg is −2.9% (95% CI, −16.5–10.7%), and −0.5% (95% CI, −13.5–12.5%) between anaprazole 40 mg and Rabeprazole 10 mg, in the FAS population. Based on the investigator review, the ulcer healing rates of the 10 mg rabeprazole, 20 mg anaprazole, and 40 mg anaprazole groups were 72.0, 70.2, and 77.1%, respectively, in the FAS population and 75.6, 72.1, and 79.5%, respectively, in the PPS population. The ulcer healing rate difference between anaprazole 20 mg and Rabeprazole 10 mg is −1.8% (95% CI, −19.8–16.3%), and 5.1% (95% CI, −12.2–22.3%) between anaprazole 40 mg and Rabeprazole 10 mg, in the FAS population. Most patients (>90%) eventually achieved complete symptom relief. The incidence rates of adverse events were of no significant differences among the treatment groups. Potential possible better liver tolerance was observed in two anaprazole dose groups than rabeprazole 10 mg group.Conclusion: Both at a dosage of 20 and 40 mg daily, anaprazole, is effective with good safety profile in the treatment of active duodenal ulcers in this Phase 2 study, which allows anaprazole to be advanced to a phase III clinical trial.Clinical Trial Registration:https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT04503629&cntry=&state=&city=&dist=, Identifier: CTR20181464, NCT04503629.

scholarly journals Recurrence of Acute Duodenal Ulcer

1994 ◽  
Vol 8 (1) ◽  
pp. 21-26
Author(s):  
RJ Bailey ◽  
IG Morrison-Cleator ◽  
A Farley ◽  
A Archambault ◽  
M Oravec ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Multicentre Trial ◽  
Epigastric Pain ◽  
Symptomatic Relief ◽  
Ulcer Recurrence ◽  
Double Blind ◽  
Duodenal Ulcers ◽  
Treatment Groups ◽  
Ulcer Healing Rate

Nizatidine, 300 mg once nightly, was compared with cimetidine, 800 mg once nightly, for treatment of 212 adult out-patients with acute duodenal ulcers in an eight-week randomized, double-blind, multicentre trial. Patients were endoscoped at weeks 2, 4 and 8, regardless of ulcer healing status. No significant differences in ulcer healing rates between treatment groups were seen at weeks 2 and 4, but at week 8, nizatidine had a significantly higher ulcer healing rate (P=0.036) than cimetidine (86% versus 74%, respectively). Patients with healed ulcers at either week 2 or week 4 had a final endoscopy performed at week 8. The rate of ulcer recurrence was significantly greater (P=0.021) in the cimetidine group at week 8 compared with the nizatidine group: 21% versus 7.3%, respectively. Increasing tolerance to H2receptor antagonist therapy with prolonged use may explain the higher recurrence rate of cimetidine. Both drugs provided equally rapid and effective symptomatic relief from epigastric pain after two weeks of therapy. Both were equally safe and free from treatment-related adverse effects.

scholarly journals Effect of Laser Irradiation at Different Wavelengths (940, 808, and 658 nm) on Pressure Ulcer Healing: Results from a Clinical Study

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
J. Taradaj ◽  
T. Halski ◽  
M. Kucharzewski ◽  
T. Urbanek ◽  
U. Halska ◽  
...  
Keyword(s):  
Laser Therapy ◽  
Ulcer Healing ◽  
Healing Rate ◽  
Pressure Ulcers ◽  
Maximum Output Power ◽  
Maximum Output ◽  
Average Dose ◽  
Radiation Emission ◽  
Group I ◽  
Ulcer Healing Rate

The aim of the study was to assess the efficacy of laser therapy (at different wavelengths: 940, 808, and 658 nm) for treating pressure ulcers. The primary endpoint in this trial included both the percentage reduction of the ulcer surface area and the percentage of completely healed wounds after one month of therapy (ulcer healing rate). The secondary endpoint was the ulcer healing rate at the follow-up evaluation (3 months after the end of the study). In total, 72 patients with stage II and III pressure ulcers received laser therapy once daily, 5 times per week for 1 month using a (GaAlAs) diode laser with a maximum output power of 50 mW and continuous radiation emission. Three separate wavelengths were used for the laser treatment: 940 nm (group I), 808 nm (group II), and 658 nm (group III). An average dose of 4 J/cm2was applied. In group IV, a placebo was applied (laser device was turned off). The laser therapy at a wavelength of 658 nm appeared to be effective at healing pressure ulcers. The wavelengths of 808 and 940 nm did not have any effect in our study.

Ankle Motility is a Risk Factor for Healing of Chronic Venous Leg Ulcers

2001 ◽  
Vol 16 (1) ◽  
pp. 38-40 ◽  
Author(s):  
J. R. Barwell ◽  
M. Taylor ◽  
J. Deacon ◽  
C. Davies ◽  
M. R. Whyman ◽  
...  
Keyword(s):  
Risk Factor ◽  
Pump Power ◽  
Ulcer Healing ◽  
Independent Risk Factor ◽  
Healing Rate ◽  
Leg Ulcer ◽  
Venous Leg Ulcer ◽  
Compression Bandaging ◽  
Venous Ulcers ◽  
Ulcer Healing Rate

Objective: To investigate the effect of ankle motility on chronic venous leg ulcer healing, and to relate this to calf pump function and muscle bulk. Methods: This was a prospective cohort study undertaken in a leg ulcer clinic. Ankle motility, calf-ankle circumference ratio and calf pump power (derived from digital photoplethysmography) were assessed as to their effect on ulcer healing rate. Thirty consecutive patients undergoing multi-layer compression bandaging for open chronic venous ulcers were included. Results: Ankle motility was an independent risk factor for ulcer healing ( p = 0.001, hazard ratio 1.08, 95% CI 1.03–1.13). Ankle motility correlated with calf-ankle circumference ratio ( r = 0.48, p<0.01). No relationship was found between photoplethysmography-derived calf pump power, ankle motility or ulcer healing rate. Conclusions Ulcers in legs with poor ankle motility are slower to heal and this may be related to reduced calf muscle bulk. Ankle exercises or physiotherapy could be considered in such patients.

EFFECT OF SUPPORT SURFACE ON PRESSURE ULCER HEALING RATE*

2004 ◽  
Vol 31 (Supplement) ◽  
pp. S2
Author(s):  
Rachel Ochs ◽  
Susan Horn ◽  
Randall Smout ◽  
Lia van Rijswijk
Keyword(s):  
Pressure Ulcer ◽  
Ulcer Healing ◽  
Healing Rate ◽  
Support Surface ◽  
Ulcer Healing Rate ◽  
Effect Of Support

scholarly journals Safety Profile of Ceftazidime–Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme

Drug Safety ◽  
2020 ◽  
Vol 43 (8) ◽  
pp. 751-766
Author(s):  
Karen Cheng ◽  
Paul Newell ◽  
Joseph W. Chow ◽  
Helen Broadhurst ◽  
David Wilson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Safety Profile ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Pooled Data ◽  
Adult Phase ◽  
Clinical Trial Programme

A randomized, double-blinded, placebo-controlled multicenter phase II trial of adjuvant immunotherapy with tecemotide (L-BLP25) after R0/R1 hepatic colorectal cancer metastasectomy (LICC): Final results.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 480-480
Author(s):  
Carl Christoph Schimanski ◽  
Stefan Kasper ◽  
Susanna Hegewisch-Becker ◽  
Jan Schroeder ◽  
Friedrich Overkamp ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Cox Regression ◽  
Phase Ii Trial ◽  
Stage Iv ◽  
High Recurrence Rate ◽  
Muc1 Expression ◽  
Double Blinded ◽  
Clinical Trial Information

480 Background: Hepatic metastasectomy is the only potential curative treatment option for stage IV colorectal cancer (CRC) limited to liver metastases (LM). After R0 resection of LM the high recurrence rate remains a major challenge. L-BLP25 is an antigen-specific cancer vaccine targeting mucin 1 (MUC1). The LICC trial aimed to improve survival outcome in mCRC patients (pts) after R0/R1 LM resection. Methods: This LICC trial, a binational, multicenter, double-blinded, placebo controlled phase II trial, included pts with stage IV LM limited CRC after resection of primary tumor and LM (R0/R1) within the last 8 weeks, ECOG 0/1 and adequate organ function. Pts were 2:1 randomized to receive L-BLP25 or placebo. L-BLP25 930 µg was administered as 8 weekly subcutaneous doses followed by 6 week maintenance intervals until recurrence or a maximum of 2 years. Cyclophosphamide 300 mg/m2 (CP) or matching saline (NS) was given intravenously 3 days prior to first L-BLP25/placebo. Co-primary endpoints were recurrence-free survival (RFS) and 3-year overall survival (OS), secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety. Differences in RFS and OS were analyzed with exploratory log-rank tests on the intention-to-treat population. Results: Of 121 pts enrolled between Oct 2011 and Dec 2014, 79 pts received L-BLP25+CP, 42 placebo+NS. Baseline characteristics were well balanced. Median age was 60 years. Median RFS was 6.1 (90% CI: 5.8-8.8) vs. 11.4 months (90% CI: 5.0-20.3) and estimated 3-year OS rate 69.1% vs. 79.1% for L-BLP25 and placebo, respectively. Two-factorial Cox regression models showed no impact of MUC1 expression or treatment on RFS or OS. The most common L-BLP25-related grade 3/4 adverse events were diarrhea, anemia and back pain. There was one death in the L-BLP25 arm due to Merkel cell carcinoma assessed by the investigator as being potentially related to vaccination. Conclusions: The LICC trial failed to meet its primary endpoint of significantly improving RFS and OS with L-BLP25. MUC1 expression was not associated with outcome. Clinical trial information: NCT01462513 . Clinical trial information: NCT01462513.

Recombinant humanized anti-PD-1 monoclonal antibody toripalimab in patients with metastatic urothelial carcinoma: Results of an open-label phase II clinical study Polaris-03.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5040-5040
Author(s):  
Xinan Sheng ◽  
Haige Chen ◽  
Bin Hu ◽  
Xudong Yao ◽  
Ziling Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Urothelial Carcinoma ◽  
Clinical Response ◽  
Disease Progression ◽  
Phase Ii ◽  
Safety Profile ◽  
Clinical Activity ◽  
Phase Ii Clinical Study ◽  
Metastatic Urothelial Carcinoma

5040 Background: Patients with advanced metastatic urothelial carcinoma (UC) who experience disease progression after standard therapy have limited treatment options. Phase I study of toripalimab in subjects with heavily pretreated metastatic UC had demonstrated an acceptable safety profile and promising clinical activity. Here we report the safety and efficacy result of toripalimab in a phase II clinical study (POLARIS-03) in Chinese patients with metastatic urothelial carcinoma. (Clinical trial ID: NCT03113266). Methods: Metastatic UC Patients receive toripalimab 3 mg/kg Q2W until disease progression, unacceptable toxicity or voluntary withdrawal. Clinical response is assessed every 8 weeks. Tumor PD-L1 expression and other biomarkers will be evaluated for correlation with clinical response. Results: From May 2017 to September 2019, 204 patients were screened and the study enrollment was completed with 151 patients enrolled from 15 participating centers. The median age was 62 years and 66% were male. 87% patients had visceral metastasis. By the cut-off date of Jan 6, 2020, 92.1% (139/151) patients experienced treatment related adverse event (TRAE) and grade 3 and above TRAE occurred in 35.8% (54/151) patients. Most common TRAE included anemia, triglycerides increased, proteinuria, fatigue, and hyperglycemia. Treatment discontinuation due to a TRAE occurred in 6 (4.0%) patients, while dose delay due to a TRAE occurred in 23 (15.2%) patients. Three patients with major protocol deviations were excluded from efficacy analysis. Among 148 patients assessed by IRC per RECISTv1.1, 2 CR, 36 PR, and 30 SD were observed for an ORR of 25.7% and a DCR of 45.9%. The median DOR was 15.7 months. The median PFS was 1.9 months, and the median OS was estimated 20.8 months. PD-L1 expression results were obtained from 141 patients. PD-L1+ patients (n=46) had significant better ORR than PD-L1- patients (n=95), 41.3% versus 16.8% ( p<0.01). Conclusions: Toripalimab has demonstrated encouraging clinical activity in chemo-refractory UC patients with a manageable safety profile. Patients will be continuously monitored for safety and overall survival. Clinical trial information: NCT03113266 .

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