Clinical efficacy, safety and pharmacokinetics of a newly developed controlled release morphine sulphate suppository in patients with cancer pain

2000 ◽  
Vol 56 (3) ◽  
pp. 219-223 ◽  
Author(s):  
F. Moolenaar ◽  
W. J. Meijler ◽  
H. W. Frijlink ◽  
J. Visser ◽  
J. H. Proost
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Clinical Efficacy ◽  
Morphine Sulphate ◽  
Patients With Cancer

Clinical efficacy and safety of a novel controlled-release morphine suppository and subcutaneous morphine in cancer pain: a randomized evaluation.

1995 ◽  
Vol 13 (6) ◽  
pp. 1520-1527 ◽  
Author(s):  
E Bruera ◽  
R Fainsinger ◽  
K Spachynski ◽  
N Babul ◽  
Z Harsanyi ◽  
...  
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Clinical Efficacy ◽  
Oral Morphine ◽  
Mcgill Pain Questionnaire ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference

PURPOSE A significant number of cancer patients will require an alternate route of morphine administration at some point during their illness. This study compared the clinical efficacy and safety of a novel morphine sulfate controlled-release suppository (MS-CRS) and subcutaneous (SC) morphine in patients with cancer pain. METHODS Thirty patients with cancer pain were randomized in a double-blind crossover study to MS-CRS every 12 hours or SC morphine every 4 hours for 4 days each, using a 2.5:1 analgesic equivalence ratio. Pain intensity was assessed using a visual analog scale (VAS) and the Present Pain Intensity Index of the McGill Pain Questionnaire. Nausea and sedation were also assessed with a VAS. Evaluations were made by the patient at 8 AM, noon, 4 PM, and 8 PM and rescue morphine consumption recorded. RESULTS Twenty-three patients completed the study (13 men and 10 women; mean age, 64.0 +/- 2.0 years) and were treated with mean daily MS-CRS and SC morphine doses of 326 +/- 69 mg and 138 +/- 28 mg, respectively. There was a small but significant difference in overall ordinal pain-intensity scores in favor of MS-CRS (0.7 +/- 0.1 v 0.9 +/- 0.1, P = .0459). There were no significant differences between MS-CRS and SC morphine in overall VAS scores for pain intensity (13 +/- 3 v 13 +/- 3 mm), sedation (23 +/- 3 v 25 +/- 4 mm), and nausea (8 +/- 2 v 9 +/- 2 mm). The mean daily rescue analgesic consumption during MS-CRS and SC morphine did not differ significantly (1.2 +/- 0.4 v 1.2 +/- 0.4 doses/d). CONCLUSION MS-CRS, administered every 12 hours, provides analgesia comparable to SC morphine and represents a reliable, noninvasive alternative method of pain control for patients unable to take oral morphine.

A novel morphine sulphate preparation: clinical trial of a controlled-release morphine suspension in cancer pain

1993 ◽  
Vol 7 (4) ◽  
pp. 301-306 ◽  
Author(s):  
Walter B Forman ◽  
Russell K Portenoy ◽  
Ronald H Yanagihara ◽  
Curtis Hunt ◽  
Rebecca Kush ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Release ◽  
Cancer Pain ◽  
Morphine Sulphate

Comparative clinical efficacy and safety of immediate release and controlled release hydromorphone for chronic severe cancer pain

Cancer ◽  
1994 ◽  
Vol 74 (6) ◽  
pp. 1808-1816 ◽  
Author(s):  
Helen Hays ◽  
Neil Hagen ◽  
Michael Thirlwell ◽  
H. Dhaliwal ◽  
Najib Babul ◽  
...  
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Clinical Efficacy ◽  
Immediate Release ◽  
Efficacy And Safety

Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain.

1998 ◽  
Vol 16 (10) ◽  
pp. 3222-3229 ◽  
Author(s):  
E Bruera ◽  
M Belzile ◽  
E Pituskin ◽  
R Fainsinger ◽  
A Darke ◽  
...  
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Treatment Preference ◽  
Dose Ratio ◽  
Double Blind ◽  
Patients With Cancer ◽  
Elimination Half ◽  
Global Ratings ◽  
History Of ◽  
Controlled Release Formulations

PURPOSE Use of oxycodone for chronic cancer pain has been hampered by its short elimination half-life. This study was designed to compare the efficacy and safety of controlled-release formulations of oxycodone and morphine for cancer pain. PATIENTS AND METHODS Thirty-two adult patients with cancer pain and a > or = 3-day history of stable analgesia with oral opioids provided written informed consent and were randomized to controlled-release oxycodone or controlled-release morphine for 7 days. To blind the study using available tablet strengths, the dose ratio of oxycodone to morphine was set at 1:1.5. On day 8, patients were crossed over to the alternate drug for 7 days. Pain intensity was assessed using a visual analog scale (VAS 0 to 100 mm) and a categorical scale (CAT 0 to 4). Side effects were assessed using a checklist (four-point categorical severity) and a nondirected questionnaire. Patients and investigators made blinded global ratings of efficacy and treatment preference. RESULTS Twenty-three patients completed the study (10 men, 13 women). The VAS and CAT scores were (mean+/-SD) 23+/-21 and 1.2+/-0.8 on controlled-release oxycodone, and 24+/-20 (P=.43) and 1.3+/-0.7 (P=.36) on controlled-release morphine. No period or carryover effect was detected. There were no significant differences in adverse effects (P=.40) or ratings of efficacy and preference. The median oxycodone/morphine dose ratio was 1.5 and the maximum was 2.3. CONCLUSION Controlled-release oxycodone is as safe and effective as controlled-release morphine in the treatment of cancer pain.

Twice-daily versus once-daily morphine sulphate controlled-release suppositories for the treatment of cancer pain

1999 ◽  
Vol 7 (4) ◽  
pp. 280-283 ◽  
Author(s):  
Eduardo Bruera ◽  
Michelle Belzile ◽  
Catherine M. Neumann ◽  
I. Ford ◽  
Zoltan Harsanyi ◽  
...  
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Morphine Sulphate ◽  
Once Daily
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