scholarly journals Comparison of safety and efficacy of dextromethorphan and levocloperastine in treatment of dry cough: a randomized open label phase IV clinical trial

2019 ◽  
Vol 8 (10) ◽  
pp. 2284
Author(s):  
Arijit Ghosh
Keyword(s):  
Clinical Trial ◽  
Selection Criteria ◽  
Open Label ◽  
Safety And Efficacy ◽  
Leicester Cough Questionnaire ◽  
Open Label Phase ◽  
Group A ◽  
Group B ◽  
Phase Iv

Background: To compare safety and efficacy of dextromethorphan and levocloperastine in treatment of dry cough.Methods: Patients fulfilling the selection criteria were randomized into two groups. Patients in group A were administered dextromethorphan cough lozenges (5 mg) thrice daily for 7 days. Patients in group B were administered syrup levocloperastine (20 mg/5 ml) 5 ml thrice daily for 7 days. Severity and frequency of cough, and Leicester Cough Questionnaire (LCQ) score were assessed at the end of day 7.Results: Levocloperastine significantly decreased (p<0.5) severity and frequency of cough compared to dextromethorphan at day 7. Levocloperastine also significantly increased LCQ score compared to dextromethorphan at day 7.Conclusions: Levocloperastine is significantly more effective compared to dextromethorphan in treatment of dry cough. 

scholarly journals Open-label phase IV clinical trial to evaluate the effect of nasal testosterone gel on reproductive hormones and semen parameters in hypogonadal men

2019 ◽  
Vol 112 (3) ◽  
pp. e434-e435
Author(s):  
Thomas A. Masterson ◽  
Joshua N. Bitran ◽  
Manuel Molina ◽  
Emad Ibrahim ◽  
Ursula Kaiser ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Reproductive Hormones ◽  
Semen Parameters ◽  
Open Label ◽  
Testosterone Gel ◽  
Open Label Phase ◽  
Phase Iv

scholarly journals Lacrimal stenting versus three-snip punctoplasty for treatment of punctal stenosis or occlusion: An open-label, randomized clinical trial

2021 ◽  
Vol 10 (1) ◽  
pp. 24-31
Author(s):  
Haitham Rashdan ◽  
Ali Mahmoud Ismail ◽  
Mohammed Ezz-Eldawla ◽  
Mohammed Iqbal
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Punctal Plugs ◽  
Silicon Tube ◽  
Group A ◽  
Group B ◽  
Punctal Stenosis

Background: To compare the short-term anatomical and functional outcomes of, as well as patient satisfaction with, lacrimal stenting and three-snip punctoplasty for the treatment of punctal stenosis or occlusion. Methods: In this open-label, randomized clinical trial, we included 50 eyes of 30 patients diagnosed with punctal stenosis or occlusion. They were randomly allocated to two groups of 25 eyes each, using central telephone randomization. Group A underwent a lacrimal stenting procedure and was subdivided into two subgroups: Group A1 (13 eyes) received polyvinylpyrrolidone-coated perforated punctal plugs, and Group A2 (12 eyes) received closed intubation using a bicanalicular silicon tube. Group B included 25 eyes that underwent three-snip punctoplasty. All eyes were examined after 1 day, 1 week, 1 month, 3 months, and 6 months. Postoperative anatomical success assessing the punctum size, functional success using the fluorescein disappearance test, and patient satisfaction based on epiphora scoring were recorded. Results: Both study groups were comparable in terms of sex and age distribution. Compared to Group B, Group A had a significantly larger punctum size at one, three, and 6-month postoperatively (P = 0.009, 0.01, and 0.02, respectively). The difference in FDT results was significant between the two groups at all follow-up visits (P = 0.008, 0.0001, 0.003, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Likewise, patient satisfaction was significantly different between both groups at all follow-up visits (P = 0.007, 0.001, 0.005, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Conclusions: Lacrimal stenting is an effective method for the treatment of punctal stenosis or occlusion. Overall, the FDT results and patient satisfaction outcomes were significantly better. Keywords: punctal occlusion, punctal stenosis, epiphora, lacrimal stenting, closed intubation, bicanalicular silicon tube, perforated punctal plugs, three-snip punctoplasty, 3-snip punctoplasty

Apatinib as third-line or beyond therapy in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction: An open-label, multicenter, post-marketing phase IV study (Ahead-G201).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 103-103
Author(s):  
Shukui Qin ◽  
Wenying Deng ◽  
Lu Wen ◽  
Junsheng Wang ◽  
Guifang Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gastroesophageal Junction ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Phase Iii ◽  
Open Label ◽  
Safety And Efficacy ◽  
Post Marketing ◽  
Phase Iv

103 Background: The clinical benefit and safety profile of apatinib in advanced gastric cancer have been established in the randomised controlled phase III clinical trial (J Clin Oncol. 34(13):1448-54). A post-marketing study to confirm the safety and efficacy of apatinib is ongoing in a broad range of patients (pts). Methods: This is a single-arm, open-label, multi-center, Phase IV trial with the target sample size of 2000+ (ClinicalTrials.gov Identifier: NCT02426034). Pts were recruited to receive oral apatinib until disease progression, death or unacceptable toxicity. The primary objective was safety, and the secondary objectives included overall response rate (ORR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS). Results: Herein, we report the preliminary data as documented in the EDC System. As of Jul 10, 2017, 1037 pts were enrolled from 138 hospitals across China. Pts characteristics were: median age 59 yrs, male/female 72.0/28.0%, ECOG PS 0/1/≥2 16.6/66.2/17.2%, stage IV 91.0%. 336 (32.4%) pts interrupted treatment and dose modification occurred in 172 (16.6%) pts (reduction 132/12.7%; rise 87/8.4%). Eventually, the mean dosage was 526.2 mg/d. 652 (62.9%) pts had 4407 drug-related adverse events (DRAEs). Grade ≥3 DRAEs occurred in 300 (28.9%) pts. Severe AEs were reported by 221 (21.3%) pts. The most common DRAEs were proteinuria (19.3%), hypertension (18.8%), leukocyte decrease (16.4%), fatigue (14.2%), platelet decrease (13.6%), hand-foot-skin reaction (11.1%) and neutrophil decrease (10.1%). 820 pts were evaluable for efficacy analysis. The best ORR and DCR were 10.7% and 70.0%, respectively. The median PFS and OS were 4.60 (95%CI, 3.25–4.73) and 6.57 (95%CI, 5.78–7.59) months, respectively. Conclusions: Apatinib monotherapy is effective and has a favorable toxicity profile in real-world clinical setting. The preliminary results of this Phase IV study confirmed the safety and efficacy of apatinib demonstrated in the Phase II and III trials. Updated results will be discussed. Clinical trial information: NCT02426034.

scholarly journals Effects of Combination Therapy of Methotrexate with Leflunomide & Hydroxychloroquine: Comparative Clinical Trial

2020 ◽  
pp. 57-63
Author(s):  
Qurrat-ul-Ain Bukhari ◽  
Kauser Ismail ◽  
Muzna Hameed Dar ◽  
Afshan Abbas ◽  
Madiha Ata
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Global Assessment ◽  
Morning Stiffness ◽  
Combination Therapies ◽  
Open Label ◽  
Group A ◽  
Group B ◽  
Age Range

Aims: To study the role of combination therapies in the treatment of rheumatoid arthritis. Study Design:  This an open-label, randomized 180-days clinical trial. Place and Duration of Study: This study was conducted in the Department of Pharmacology and Therapeutics, BMSI and Medical unit ward 6, after approval of JPMC ethical committee, between March 2013 and May 2014. Methodology: We included 90 patients (69 women, 21 men; age range 28-62 years) which were divided into two groups, A and B. 44 patients of group A received methotrexate (MTX) 7.5-20 mg/ week orally and Leflunomide (LEF) 10-20 mg/ day QD orally as maximally tolerated. 46 patients of group B were given MTX 7.5-20 mg/ week orally and Hydroxychloroquine (HCQ) 200 mg twice daily orally as maximally tolerated. Results: Comparing the combination of group A with group B, group A showed highly significant improvement in mean patient’s global assessment (1.4 ± 0.66) and mean pain (1.3 ± 1.11) as compared to group B (2.4 ± 1.14, 2.2 ± 1.49). The drugs of group B showed significant improvement in mean physician’s global assessment (1.7 ± 0.92) and mean morning stiffness (49.2 ± 10.59) as compared to group A (2.8 ± 0.97, 54.4 ± 10.14). Combination treatment of group B showed significantly lower adverse effects (4.3%) as compared to group A (11.4%). Statistical analysis revealed that patients receiving both the combinations responded equally in terms of effects but group B showed significantly better in terms of adverse effects. Conclusion: Both combinations of MTX & LEF and MTX & HCQ were well tolerated but the efficacy of MTX and HCQ was significantly superior in terms of adverse effects to the combination of MTX and LEF.

Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China

Vaccine ◽  
2020 ◽  
Vol 38 (40) ◽  
pp. 6274-6279
Author(s):  
Shaohong Yan ◽  
Haiping Chen ◽  
Zhenguo Zhang ◽  
Shaoying Chang ◽  
Yanhui Xiao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Open Label ◽  
Randomized Controlled ◽  
Open Label Phase ◽  
Phase Iv
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