Research

Novartis-OIC-201 Constipation Research Study

Volunteers are needed to participate in a research study evaluating whether the investigational use of an approved medication will safely and effectively relieve constipation caused by pain medicine.Constipation is the most frequent side effect of some prescribed pain medications. Some people become constipated shortly after starting their pain medication; for others, constipation does not become a problem until they are on certain doses. No matter when you experience it, it’s uncomfortable and can be debilitating.

Physicians at South Bay Gastroenterology Medical Group are participating in this nationwide research study. Individuals that have had non-cancer pain for at least three months and experience constipation because of their prescription pain medication may qualify. If you take part, you will receive all study-related care at no charge, including physical examinations, laboratory services, and investigational medication. Financial compensation may also be provided.

For more information, please contact vickie@southbaygastro.com


Do you experience constipation caused by your pain medication?

It’s not uncommon; in fact, constipation is the most frequent side effect of some prescribed pain medications. Some people become constipated shortly after starting their pain medication; for others, constipation does not become a problem until they’re on certain doses. No matter when you experience it, it’s uncomfortable and can be debilitating. This condition is commonly known to your doctor as opioid induced constipation or pain medication induced constipation.


Is there medication for constipation?

Yes. Many physicians will recommend over the counter treatments when and if constipation becomes a problem. Most commonly, individuals use fiber supplements, laxatives, or stool softeners to relieve their discomfort.


Research Study Opportunity

Our physicians are evaluating whether the investigational use of an approved medication will safely and effectively relieve constipation caused by pain medicine. You may qualify if you:

  • Have had non-cancer pain for at least 3 months
  • Experience constipation caused by prescription pain medication

All study-related care is provided, including physical examinations, laboratory services, and study medication.

For more information, please contact vickie@southbaygastro.com


What Is A Clinical Trial?

A clinical trial, also referred to as a research study, is a scientific study of investigational medical treatments, drugs, or devices in people. The purpose of each clinical trial may vary depending on which stage of research the investigational medical treatment, drug, or device has reached. Stages of research include: Phase I, Phase II, Phase III and Phase IV.

A clinical trial may show that the study treatment being studied is better than, as good as, or no better than the standard treatment. Or it may confirm the discovery of a successful treatment for a disease that previously had no treatment options.

Pharmaceutical companies or other health organizations are typically the sponsors of these clinical trials. They are responsible for funding and for designing its protocol. The protocol is the detailed guideline for conducting the study. Only trained doctors, nurses, and other medical staff conduct the study itself. Patients in clinical trials are volunteers who qualify for the study, sign an Informed Consent and take part.

The Food and Drug Administration (FDA) requires the satisfactory completion of clinical trials before it will approve a new treatment, drug or device as safe and effective for public use. Clinical trials are the link between research and the relief of human suffering.


Should I Volunteer?

Volunteers are important to the clinical study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of further research and testing in the development of future treatments for constipation caused by pain medication.

Each year, thousands of people volunteer to participate in clinical drug studies. Qualified participants will:

  • Participate in the research process that may lead to new therapies
  • Receive medical monitoring related to your condition
  • Learn new information about your condition

Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and the development of new therapies.

Participation in this clinical research study is completely voluntary.

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