An open-label, randomized, multicenter, comparative study of the efficacy and safety of 7 days of treatment with clarithromycin extended-release tablets versus clarithromycin immediate-release tablets for the treatment of patients with acute bacterial exacerbation of chronic bronchitis

2002 ◽  
Vol 24 (12) ◽  
pp. 2105-2122 ◽  
Author(s):  
Karl Weiss ◽  
Anita Vanjaka
Keyword(s):  
Comparative Study ◽  
Chronic Bronchitis ◽  
Extended Release ◽  
Immediate Release ◽  
Efficacy And Safety ◽  
Open Label

Oxymorphone and oxymorphone extended release: A pharmacotherapeutic review

2018 ◽  
Vol 4 (3) ◽  
pp. 131 ◽  
Author(s):  
Paul Alexander Sloan, MD ◽  
Robert L. Barkin, PharmD, MBA
Keyword(s):  
Chronic Pain ◽  
Extended Release ◽  
Analgesic Efficacy ◽  
Opioid Analgesics ◽  
Immediate Release ◽  
The United States ◽  
Efficacy And Safety ◽  
Open Label ◽  
Opioid Agonist ◽  
Noncancer Pain

The treatment of chronic pain remains an enormous challenge in the United States. Opioid analgesics are an important component of pharmacotherapy for chronic pain and have proven efficacy in the management of cancer and noncancer chronic pain. The newest addition to oral opioid pharmacotherapy is oral oxymorphone, a semisynthetic opioid agonist that is now available in oral immediate-release (IR) and extended-release (ER) formulations. This review discusses the pharmacology, pharmacokinetics, pharmacodynamics, pharmacotherapeutics, and clinical use of oral oxymorphone IR and ER formulations for the management of moderate to severe pain for different types of patients in a variety of settings. Two published studies evaluated the efficacy and safety of oxymorphone IR in patients with moderate to severe postoperative pain and demonstrated that it provides rapid and effective analgesia and is generally well tolerated. Six published randomized controlled trials and three published open-label studies evaluated the efficacy and safety of oxymorphone ER for chronic cancer or noncancer pain. These trials found analgesic efficacy and tolerability comparable to that provided by morphine controlled release (CR) or oxycodone CR; treatment effects with oxymorphone ER were durable for treatment periods of 12 weeks at the same dose or up to 1 year with little dose escalation. Titrated doses of oxymorphone ER were effective and generally well tolerated in both opioid-experienced and opioid-naïve patients. Aspects of oxymorphone metabolism and limited protein binding may simplify treatment in certain populations.

Clinical Efficacy and Safety of “Vasavaleha” in the Management of Stable Chronic Bronchitis: A Prospective Open Label Multicenter Study

2017 ◽  
Vol 1 (4) ◽  
pp. 231-237
Author(s):  
Varanasi Subhose ◽  
Shweta Chaudhary ◽  
G Babu ◽  
Milind Suryavanshi ◽  
Hari ML Meena ◽  
...  
Keyword(s):  
Chronic Bronchitis ◽  
Clinical Efficacy ◽  
Multicenter Study ◽  
Efficacy And Safety ◽  
Open Label

Efficacy and safety of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in patients with moderate-to-severe chronic low back pain

2015 ◽  
Vol 11 (6) ◽  
pp. 507 ◽  
Author(s):  
Martin E. Hale, MD ◽  
Thomas R. Zimmerman, MD ◽  
Eli Eyal, MSc ◽  
Richard Malamut, MD
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Extended Release ◽  
Study Drug ◽  
Low Back ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Drug Loss ◽  
Efficacy Measure

Objective: To evaluate efficacy and safety of hydrocodone bitartrate extended-release (ER) tablets developed with CIMA® Abuse-Deterrence Technology (ADT) versus placebo in alleviating moderate-to-severe pain in patients with chronic low back pain.Design: Phase 3, randomized, double-blind study consisting of a screening period (7-14 days), open-label titration period (≤6 weeks), and double-blind treatment period (≤12 weeks).Setting: Seventy-eight US centers.Main outcome measures: Changes from baseline at week 12 in weekly average of daily worst pain intensity (WPI; primary efficacy measure), weekly average pain intensity (API; secondary efficacy measure), adverse events (AEs), and study drug loss and diversion.Results: Patients (N = 625) who entered open-label dose titration and identified the analgesic hydrocodone ER dose (30-90 mg every 12 h) providing optimal pain relief with minimal AEs were randomized to hydrocodone ER (n = 191) or placebo (n = 180) for double-blind treatment at the identified dose; 297 patients completed the study. Least squares means [SE] changes from baseline were significantly greater (worsening pain; 11-point scale) with placebo than hydrocodone ER in weekly average of daily WPI (0.74 [0.15] vs 0.11 [0.14]; p < 0.001) and weekly API (0.55 [0.14] vs −0.03 [0.12]; p < 0.001). The most common AEs with hydrocodone ER were constipation (14 percent) and nausea (10 percent). Study drug loss (≤4 percent) and diversion (≤2 percent) rates were low.Conclusions: Hydrocodone ER formulated with ADT was significantly more effective than placebo in alleviating chronic low back pain and demonstrated a safety profile consistent with that of opioids, with a low occurrence of study drug loss and diversion.

Microsphere oxycodone for pain management in head and neck cancer (HNC) patients receiving radiotherapy.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 123-123
Author(s):  
Andrew Michael McDonald ◽  
Sharon Spencer ◽  
Christopher Douglas Willey ◽  
James A. Bonner ◽  
Thomas A Swain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Extended Release ◽  
Common Adverse Effect ◽  
Immediate Release ◽  
Gastrostomy Tube ◽  
World Health ◽  
Future Research ◽  
Transdermal Fentanyl ◽  
Open Label ◽  
Opioid Dose

123 Background: Pain is a common adverse effect of RT in patients with HNC, and extended release analgesic options are limited due to high rates of dysphagia. Wax microsphere bound oxycodone was developed as an abuse-deterrent opioid and maintains a similar pharmacokinetic profile whether administered with or without an intact capsule. We hypothesized that microsphere oxycodone could be used for extended release analgesia in patients undergoing RT for HNC and would not need to be discontinued due to dysphagia or gastrostomy tube dependence. Methods: We performed an open-label prospective clinical trial (NCT03317730) to assess the feasibility of microsphere oxycodone for extended release analgesia during RT for HNC. Participants were > 18y, had histologically confirmed HNC, and were to receive > 50 Gy of RT. Analgesia was prescribed in accordance with the World Health Organization pain ladder. Non-opioid and immediate release opioids were used at the discretion of the treating physicians. Microsphere oxycodone was initiated when total daily opioid dose exceeded 30mg morphine sulfate equivalent and was titrated weekly during RT. The primary feasibility endpoint was frequency of microsphere oxycodone discontinuation within 3 months of RT for reasons other than pain resolution. Secondary endpoints included pain level during RT. Results: Twenty-six eligible patients were enrolled between June and November, 2018. Microsphere oxycodone was initiated in 13 (50%) patients at a median of 5 weeks after beginning RT (range: 0 – 7 weeks). The mean Brief Pain Index Severity composite score at time of microsphere oxycodone initiation was 5.4 (SD ±2.0) and was 4.8 (SD ±1.5) during the final week of RT ( p= 0.21). Six patients utilized a gastrostomy tube to administer microsphere oxycodone for all or part of RT. Microsphere oxycodone was discontinued in 1 (7.6%) patient due to perceived inefficacy, 0 patients due to toxicity, and 0 patients due to difficulty with administration. Conclusions: These results support the feasibility and safety of microsphere oxycodone for extended release analgesia in patients with HNC undergoing RT. Future research should compare microsphere oxycodone and transdermal fentanyl in this population. Clinical trial information: NCT03317730.

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