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

In a Phase IIb trial, Addex’s ADX10059 increased performed well in the treatment of gastroesophageal reflux disease (GERD). The four-week trial, which comprised 103 patients, showed ADX10059 significantly increased the number of symptom-free days for patients that took the drug compared to patients on a placebo. Patients involved in the trial had previously responded well to a group of drugs widely used for combating acid reflux called proton pump inhibitors, (PPIs).

The trial also showed that the medication was well tolerated among those in the trial. While adverse events were reported more often among those taking ADX10059 than the placebo group, the company reports that the vast majority of events were mild and none were described as severe. Participants who took ADX10059 also indicated a reduction in sleep disturbance compared to those in the placebo group, according to a patient questionnaire.

Addex says it has also completed patient recruitment for another trial of ADX10059, which combines the medication with PPIs. Results on that trial are expected in January 2010.

The results set Addex up to license the drug to a larger pharmaceutical company, which is anticipated sometime in 2010. Some estimates say a partnership could generate as much as $1.25 billion in annual sales.

Source: Addex Pharmaceuticals

SOURCE: Reglan Side Effects › New heartburn medication meets expectations in drug trial

GERD is a condition thought to be the result of an acid burn caused by stomach acid splashing up into the esophagus. It is often treated with medications that reduce stomach acid, such as Reglan (metoclopramide). But the new study squashes the “acid burn” belief. “Chemical injuries develop immediately,” the study’s leader, Dr. Stuart Spechler, told Reuters. “If you spill battery acid on your hand, you don’t have to wait a month to see the damage.”

Researchers say that the findings from the new study could change the way GERD is treated. “Currently, we treat GERD by giving medications to prevent the stomach from making acid,” said Dr. Rhonda Souza. “But if GERD is really an immune-mediated injury, maybe we should create medications that would prevent these cytokines from attracting inflammatory cells to the esophagus and starting the injury in the first place.”

An estimated 40 percent of Americans experience symptoms of GERD at some point, and as many as 20 percent suffer from persistent symptoms. If left untreated, GERD can cause esophageal cancer.

SOURCE: Reglan Side Effects › New study may lead to different treatments for GERD

Dr. David Carroll of Surgical Specialists of Jackson, Miss., offers a completely noninvasive procedure to treat GERD that requires no injection, cutting or penetration of the skin. It is called transoral incisionless fundoplication (TIF) surgery with the EsophyX device. Dr. Carroll says he has performed the procedure many times laparoscopically over the past 15 years, but the new EsophyX device allows him to perform the surgery using an endoscope inserted through the patients’ mouths.

“It developed over the last several years. The results are really good,” Dr. Carroll told the Clarion Ledger. He performed the first TIF with the EsophyX in Mississippi on 46-year-old Connie Braswell of Pearl, Miss. Braswell had treated her GERD symptoms for years with Nexium, but last year her symptoms worsened. “It got to the point where I was burping every day, all day long. It was very irritating,” she says.

Two gasterenterologists and two general practitioners tried her on various medications, including Reglan (metoclopramide), but nothing worked. She began restricting her diet, giving up dairy products, spicy food, coffee, and her beloved Dr. Pepper. She shed 28 pounds in the process, but she wasn’t happy. She missed the foods she used to enjoy.

Then Dr. Carroll told her about the new, noninvasive procedure using the EsophyX device, and it changed her life. “I prayed and prayed to get better and nothing else worked,” she says. “and this is working.”

Pictured are Dr. David Carroll, Dr. Jeffrey Glover and Dr. David Miller of Surgical Specialists of Jackson.

SOURCE: Reglan Side Effects › Non-surgical procedure offers hope to patients with GERD

The study, conducted by researchers from Copenhagen University, involved 120 healthy participants who took either an inactive placebo or 40 mg of the PPI drugs daily for three months. Each patient filled out a Gastrointestinal Symptom Rating Scale weekly to gauge symptoms. Researchers found that a greater percentage of people taking the PPI experienced at least one worrisome acid-related symptom during the treatment than those taking a placebo.

“We find it highly likely that the symptoms observed in this trial are caused by rebound acid hypersecretion and that this phenomenon is equally relevant in patients treated long term with PPIs. If rebound acid hypersecretion induces acid-related symptoms, this might lead to PPI dependency. Our results justify the speculation that PPI dependency could be one of the explanations for the rapidly and continuously increasing use of PPIs,” said Dr. Christian Reimer, the study’s lead author.

These findings show that safe treatment options for people suffering from GERD are limited. Earlier this year, Reglan (metoclopramide), another treatment for the condition, received a black box warning from the Food and Drug Administration (FDA) after numerous reports that people taking Reglan began to suffer suffer from a serious, involuntary movement disorder known as Tardive Dyskinesia. The black box warning advises that the medication not be taken for more than 12 weeks as the risk of contracting the disorder increases to about 20 percent among those taking the drug long term.

Experts advise suffers of GERD should consult with their physicians to find the safest treatment options.

SOURCE: Reglan Side Effects › Heartburn, GERD treatments linked to serious complications