Clinical trials are medical research studies involving people that seek to prevent disease, find treatments, diagnose diseases, or control symptoms. Trials on experimental drugs, such as the GERD study, aim to identify if the drug is safe, has side effects, works better than currently used treatments, and helps users feel better. Experimental drugs are not tested on people unless they show promising results in laboratory tests.

GERD is a chronic condition in which the liquid contents of the stomach regurgitate or back up into the esophagus. This liquid can inflame and irritate the lining of the esophagus, causing symptoms such as heartburn, sour taste in the back of the throat, a dry cough and interrupted sleep. If left untreated, it can also lead to esophageal cancer.

Treatments include diet changes and medication. While many drugs are available over-the-counter to treat heartburn, more potent prescription alternatives are limited. One common prescription treatment is Reglan (metoclopramide), however the drug carries an FDA black box warning of a serious, involuntary movement disorder known as Tardive Dyskinesia. For sufferers of GERD, identifying a safe and effective treatment could be life changing.

SOURCE: Reglan Side Effects › Participants needed for clinical trial on new GERD treatment

GERD “disrupts sleep, causes insomnia, and is associated with daytime impairment,” says Dr. Susan M. Harding with the University of Alabama at Birmingham, and may lead sufferers to seek treatment for sleep issues rather than for the condition that is causing the sleep disturbance.

The problem, says Dr. Anthony J. DiMario Jr., who leads a research study on the subject at Thomas Jefferson University, widely prescribed Ambien (zolpidem), which works to suppress nocturnal arousals to aide in restorative sleep, also helps people sleep through their symptoms of GERD. Those who sleep through their symptoms may forgo treatment to stop the symptoms and thus may suffer even worse complications.

GERD can be treated through lifestyle changes, such as raising the head of the bed so that the sufferer doesn’t sleep flat, eating smaller meals, and avoiding foods that promote reflux, such as chocolate, peppermint, alcohol and caffeinated drinks. Some medications, both prescription and OTC, are used to treat the condition, but some carry risks.

Reglan (metoclopramide) is a prescription medication approved in the treatment of GERD. A pro-motility drug that works by stimulating the muscles of the gastrointestingal tract including the esophagus, stomach, small intestines and colon, metoclopramide has been associated with a serious movement disorder known as Tardive Dyskinesia. The condition is debilitating and can continue even after treatment has been stopped.

Sources:
Science Daily
Reuters Health Stories

SOURCE: Reglan Side Effects › Sleep aids may hinder detection of nighttime GERD