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Smooth Muscle Relaxant

Sublingual nitroglycerine for Colic

Phase 2
Waitlist Available
Led By Steven J Portouw, MD
Research Sponsored by United States Naval Medical Center, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion Criteria: Patients with right upper quadrant abdominal pain of less than 24 hours' duration between ages 18 and 60 years of age will be offered treatment with sublingual nitroglycerin or placebo.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two and five minutes
Awards & highlights

Study Summary

ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute pain of suspected biliary tract origin. Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP, (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal experience and small case reports. Nitroglycerin effect is a result of the nitric oxide component of the medication which acts as a smooth muscle relaxant in vascular, bronchial, esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently, in a metered spray form. In a case series reported by Hassel (1993), positive response times ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual nitroglycerin is most commonly used for treatment of chest pain related to insufficient cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms. Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the initial treatment of acute pain from suspected symptomatic cholelithiasis

Eligible Conditions
  • Colic
  • Biliary Tract Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two and five minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and two and five minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
pain relief on visual analog scale

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Sublingual nitroglycerineActive Control1 Intervention
Sublingual nitroglycerine followed by pain assessment and if necessary second dose of sublingual nitroglycerine
Group II: placeboPlacebo Group1 Intervention
sublingual placebo followed by pain assessment and if necessary second dose of sublingual placebo

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor
102 Previous Clinical Trials
22,654 Total Patients Enrolled
Steven J Portouw, MDPrincipal InvestigatorUnited States Naval Medical Center, San Diego

Frequently Asked Questions

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~6 spots leftby Apr 2025