Analgesic Effect of Ceruletide Compared with Pentazocine in Biliary and Renal Colic: A Prospective, Controlled, Double-Blind Study

Lishner, Michael; Lang, Ruth; Jutrin, I; De-Paolis, Chiara; Ravid, Mordchai

doi:10.1177/106002808501900607

Cited by 7 publications

(1 citation statement)

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“…These include intranasal desmopressin, aminophylline, nifedipine and methylprednisolone [ 16 ]. There are anecdotal reports of nitroglycerin use for biliary colic pain [ 17 ]. Ceruletide, a decapeptide analogue of the hormone CCK, causes relaxation of the cystic duct and sphincter of Oddi and was found to be effective in biliary and renal colic pain relief [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

Phloroglucinol-Derived Medications are Effective in Reducing Pain and Spasms of Urinary and Biliary Tracts: Results of Phase 3 Multicentre, Open-Label, Randomized, Comparative Studies of Clinical Effectiveness and Safety

Corvino

Magli

Minale³

et al. 2022

Adv Ther

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Introduction: Pain and spasms of urinary and biliary tracts are conditions causing poor quality of life. Treatment with analgesic drugs such as non-steroidal anti-inflammatory drugs and modulators of the parasympathetic system are not always tolerated, and often additional therapeutic options are necessary. The present analysis aimed to evaluate the pharmacokinetics and effectiveness of oral and parenteral preparations based on phloroglucinol in reducing pain and spasms associated with renal or biliary colic in phase 3, multicentre, open-label, randomized, comparative studies on clinical effectiveness and safety. Methods: Pharmacokinetic and pharmacodynamic studies were carried out. Four phase 3 multicentre, open-label, randomized, comparative studies were conducted to evaluate the clinical effectiveness and safety in patients with pain and spasms of urinary or biliary tracts.Eligible patients randomly received either phloroglucinol orally or via intramuscular (IM)/ intravenous (IV) administration and reference drug, dexketoprofen for urinary spasms and pain, the non-steroidal anti-inflammatory drug metamizole or scopolamine-based reference drug for biliary colic. The primary outcomes were symptoms and observed frequency of spasms, while the secondary outcome was the duration of improvement or the time between the drug administration and the recurrence of symptoms. Comparison of groups by quantitative characteristics was performed using the Ttest for independent samples or the Mann-Whitney test. Intragroup comparisons were performed using the Wilcoxon test, or the T-test for linked samples. Qualitative signs were analysed using the Pearson's v 2 test and Fisher's exact test.Results: The pharmacokinetic studies showed that (i) most of the phloroglucinol ([ 80% for IV and per os formulations) was eliminated in the first 6 h after dosing, (ii) the drug was eliminated in urine as unchanged phloroglucinol (1,3,5-trihydroxybenzene) in a small proportion (\ 3% of the dose) and (iii) a considerable amount of the drug was detected after enzymatic deconjugation with b-glucoronidase/arylsulfatase from Helix pomatia. As for the pharmacokinetic study, a total of 364

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Section: Introductionmentioning

confidence: 99%