MK-6194 for Ulcer
This study is evaluating whether a drug called MK-6194 is safe and well tolerated in people with ulcerative colitis.
See full descriptionAbout the trial for Ulcer
Treatment Groups
This trial involves 2 different treatments. MK-6194 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether MK-6194 will improve 2 primary outcomes and 13 secondary outcomes in patients with Ulcer. Measurement will happen over the course of Up to approximately 71 days.
Patient Q & A Section
What causes ulcer?
Stress, which may have been caused by the stressful life of a person during childhood, is considered a significant cause of the ulcers, especially when they are gastric ulcers. Gastritis, due to Helicobacter pylori, may also contribute to gastro-oesophageal ulcer if it remains untreated. Ulcers from NSAIDs can affect up to 50% of people with rheumatoid arthritis during the first 6 months, but the majority resolve spontaneously.
How many people get ulcer a year in the United States?
At about one hundred thousand per year, ulcer is the second most common chronic gastrointestinal condition in the United States. Data from a recent study indicate the need for more effective medical and public health programs to understand better how to prevent ulcer, and to optimize management of ulcer.
What are the signs of ulcer?
Diagnostic modalities include endoscopy, X-rays, and biopsy. Endoscopy is a major method used at the present time. It is useful in the determination of the extent of the disease and for treatment, e.g., surgery. It has not revealed any evidence that the treatment of ulcer with NSAIDs would be more effective or faster than placebo.
What is ulcer?
Ulcer is a wound-like inflammation and breakdown of tissues inside the body. In people with a gastric ulcer, there may be an inability to produce sufficient gastric acid in response to food that cannot be digested. Symptoms, which may include pain, may include a feeling of fullness. The size of the ulcer may be inversely related to hunger.\n
What are common treatments for ulcer?
We have little evidence regarding effectiveness of the treatments used for gastric ulcer in general. There is no clear consensus, however, on effective treatments. There are [no reliable clinical data about the treatments used for GI hemorrhage from any cause. Many treatments are [not used] because of lack of evidence, but some therapies used in acute and chronic peptic ulcer can be [used] for chronic bleeding as well. There are many [novel treatments being] tested for peptic ulcer that are [not yet available] for clinical use. A summary of treatments from multiple sources (including [the Mayo Clinic] and [the SCLC Center] [http://sccirc.cancer.harvard.
Can ulcer be cured?
Ulcer is a disease associated with many clinical symptoms that can vary widely with patient, situation, and observer. Most of these symptoms can be treated to some degree using drugs, non-drug measures, and/or surgery. However, many cases will remain unaltered or improved, even without current medical intervention. The cure of ulcer does not lie in altering these symptoms, but in treating the underlying causes of ulcer.
What is mk-6194?
A recent development, mk-6194 has shown safety in Phase 2 clinical trials. Mk-6194 was found to be efficacious in phase 2 studies in two distinct indications, H. pylori-specific gastritis and peptic ulcer disease. The drug's efficacy and safety profile suggest its potential for use as a novel therapy for the treatment of H. pylori infection associated gastritis and peptic ulcer disease.
What are the latest developments in mk-6194 for therapeutic use?
There is a lack of the preclinical data required by regulatory authorities for the use of mk-6194 in the clinic. Clinical trials are continuing with respect to its use in multiple myeloma and gastrointestinal cancer.
What is the average age someone gets ulcer?
The data suggests that an ulcer occurs between age 40 and 50. People that are in the later years of life are at a higher risk for presenting with an ulcer and are more likely to get the ulcer recurrent. In contrast to the average age of presentation, the average time to the recurrence of an ulcer is around 7.25 years. It therefore suggests that ulcer patients should be screened every seven to nine months at least up until age 65. There is also a higher prevalence rate for the presence of co-morbid medical conditions like hypertension, diabetes, obesity, and sleep apnea. There is also a need to establish early symptoms for future diagnosis.
How does mk-6194 work?
MK-6194 appears to be non-toxic, even when administered at high doses, and inhibits proliferation of colonocytes. Hence we conclude that the colonopathy seen in our animal model of MK-6194 treatment will be a consequence of MK-6194's activity, not a cause of it.
How serious can ulcer be?
Ulcerated lesions are the second most common indication for urgent referral to a SSCU. Although rare, they may cause substantial morbidity or, more rarely, death.