scholarly journals Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study

2018 ◽  
Vol 2018 ◽  
pp. 1-5
Author(s):  
Xiaobu Ye ◽  
MariaLisa Itzoe ◽  
Rachel Sarabia-Estrada ◽  
Louis DeTolla ◽  
Betty M. Tyler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Extended Release ◽  
Veterinary Drug ◽  
Cage Effect ◽  
Front Line ◽  
Safety Study ◽  
Observation Protocol ◽  
Cage Effects ◽  
Drug Free ◽  
Line Drug

Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg) showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug.

Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: A post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial

2014 ◽  
Vol 10 (5) ◽  
pp. 311 ◽  
Author(s):  
Srinivas Nalamachu, MD ◽  
Martin Hale, MD ◽  
Arif Khan, MD
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Extended Release ◽  
Controlled Clinical Trial ◽  
Low Back ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Titration Phase ◽  
Post Hoc

Objective: The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release (ER) in patients with chronic low back pain (LBP) with or without a neuropathic component.Design: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled clinical trial using a randomized withdrawal design, performed in patients with moderate to severe chronic LBP. Patients achieving stable doses of hydromorphone ER during a 2- to 4-week conversion and titration phase were randomized to continue treatment with hydromorphone ER or taper-down to placebo during a 12-week double-blind phase. The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale (NRS) pain intensity score from randomization to the final visit of the double-blind phase. Tolerability was assessed by recording adverse events (AEs). Data were analyzed separately for patients with non-neuropathic and neuropathic LBP.Results: A total of 173 patients with non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into the double-blind phase. During the conversion and titration phase, mean (SD) NRS scores decreased significantly from 6.5 (1.87) and 6.4 (1.99) at screening to 3.3 (0.98) and 3.2 (1.05), respectively. For both LBP subgroups, patients randomized to hydromorphone ER maintained this improvement over the double-blind treatment period, whereas those randomized to placebo reported significant increase in NRS scores. Across subgroups, the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase.Conclusions: The results of this study indicate that hydromorphone ER is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic LBP.

A phase 2 clinical trial of pemetrexed (P) plus gemcitabine (G) as front-line chemotherapy for patients with peritoneal mesothelioma (PM)

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 7235-7235 ◽  
Author(s):  
G. R. Simon ◽  
P. A. Janne ◽  
C. J. Langer ◽  
C. F. Verschraegen ◽  
A. Dowlati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Mesothelioma ◽  
Phase 2 ◽  
Front Line ◽  
Phase 2 Clinical Trial ◽  
Line Chemotherapy

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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