Treatment of Suspected Cholelithiasis With Nitroglycerin

NCT01715220 | Unknown Phase 2 DMC

• 1 other identifier: NMCSD.2012.0003
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COLIC; BILIARY TRACT DISEASES

Keywords

Nitroglycerin; Biliary Colic; Cholelithiasis; Abdominal Pain.

Outcome Measures

Primary Outcomes (1)

• pain relief on visual analog scale

  pain relief assesement at two and five minutes after medication or placebo with standard treatment if inadequate pain relief.

  two and five minutes

Study Arms (2)

Sublingual nitroglycerine

ACTIVE COMPARATOR

Sublingual nitroglycerine followed by pain assessment and if necessary second dose of sublingual nitroglycerine

Drug: sublingual nitroglycerine

placebo

PLACEBO COMPARATOR

sublingual placebo followed by pain assessment and if necessary second dose of sublingual placebo

Drug: sublingual nitroglycerine

Interventions

sublingual nitroglycerine DRUG

A convenience sample of patients presenting to the Emergency Department will be randomized to receive either sublingual 0.4 mg doses of nitroglycerin or placebo. Pain prior to and at two minutes and five minutes after medication administration will be assessed using a visual analog scale. The medication will be either a 0.4 mg dose of nitroglycerin or a placebo. If pain is not completely relieved within five minutes, a second dose will be administered after blood pressure assessment. If the pain is not completely relieved after an additional two minute and five minute assessment or the pain returns, it will be treated in the standard manner at the discretion of the treating Emergency Physician

Also known as: Nitrolingual

Sublingual nitroglycerine; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

MeSH Terms

Conditions

Colic; Biliary Tract Diseases; Cholelithiasis; Abdominal Pain

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Steven J Portouw, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

steven j portouw, MD

CONTACT

619-532-8274; steven.portouw@med.navy.mil

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)