Clinical Efficacy of Spasmofen Suppository in the Emergency Treatment of Renal ColicA randomized, double blind, double dummy comparative trial

Phase 3

Completed

• Conditions: Acute renal colic; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12614000246684
• Lead Sponsor: Mostafa Yakoot

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

typical moderate to severe unilateral abdominal or flank pain that the treating emergency physician clinically diagnosed it as renal colic with or without a positive imaging picture suggestive of renal calculi

Exclusion Criteria

pregnancy or breast-feeding;
patient size or weight far from the average for adult dose;
history of allergy to an anticholinergic or any NSAID; and history of peptic ulcer disease, gastrointestinal bleeding, perforation, or inflammatory bowel disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success, defined as a change in the Verbal Rating Scale (VRS) for pain from severe or moderate pain to none or mild at 60 minutes after the dose[at 60 minutes after the dose];Percent reductions of Visual Pain Analog Scale (VPAS) scores at 15, and 60 minutes after the dose [15, and 60 minutes after the dose ]

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse events in both groups:<br>Any adverse event reported spontaneousely by the patients and we asked about dry mouth, giddiness, decrease alertness, nausea, vomiting, agitation, itchiness or nervousness.[after the dose for 60 minutes]