Doctors would like to talk with you about medical research studying an investigational ointment that may help relieve the pain associated with anal fissures, a medical condition that causes severe pain, bleeding and itching around the anus.

An anal fissure is a break or tear in the tissue of the anus. This condition can occur in men and women of all ages. The pain associated with anal fissures most often occurs during a bowel movement and frequently lasts for one to two hours afterwards. If you have been experiencing symptoms for at least 6 weeks, you may be eligible to help medical researchers explore an investigational treatment for this painful condition.Local doctors are now conducting the APT study, a medical research study evaluating the safety and effectiveness of an investigational ointment to see if it helps relieve pain from chronic anal fissures.

Can you tell me more about the Investigational Ointment?
The investigational ointment being evaluated in the APT study is called Cellegesic. Cellegesic is a nitroglycerin ointment. It is approved in the United Kingdom, Australia and other European countries, under the name Rectogesic®, for relieving pain associated with chronic anal fissures, but not in the United States.Nitroglycerin, which has been used for over a century in treating certain heart diseases, has also shown much promise for treating anal fissures. It is believed that nitroglycerin may help cause the relaxation of the internal anal sphincter muscle which would prevent a spasm (excessive contraction) from occurring. These spasms are typically what causes the pain associated with an anal fissure.

How may I qualify for the APT study?
To be eligible for this study, you must:o Be between the ages of 18 and 75 yearso Have an anal fissure for at least 6 weeks prior to the study. Symptoms may include:- Severe pain during and after a bowel movement- Bleeding around the anus following a bowel movement- Itching around the anusQualified participants will receive study-related medical evaluations and the investigational ointment at no cost. Reimbursement for time and travel will also be provided.

What do I need to know about the APT Study?
The purpose of this study is to evaluate the safety and effectiveness of Cellegesic, in relieving the pain from a chronic anal fissure. As a participant in this study, your total participation would last approximately 4 weeks (28 days) and include up to 5 study visits.Before you are enrolled in the study you will go through an initial visit, called the screening visit, to determine your final eligibility. During this visit you will be asked several questions about your current and past health and you will undergo a study-related physical examination. You will also be given an anal examination at this time. In addition, you will be given a Visual Analogue Scale (VAS) score card which uses a horizontal line as a tool for measuring the amount of pain you feel. The site staff will instruct you on how to use this card.If you are a woman, you will also be given a pregnancy test to confirm you are not pregnant. If you are pregnant, you cannot participate in this study.Once you are enrolled in the study, you will visit the clinic approximately once a week. During these visits you will undergo a series of medical tests and evaluations monitoring your safety and measuring your progress. These study-related tests and evaluations include, but are not limited to, physical examinations, the collection of vital sign measurements (blood pressure, pulse rate), ECGs, clinical laboratory evaluations and the collection of blood and urine samples. You will be asked to bring your study medications (including ointment) to each visit along with your VAS score card. The study staff will then review this card with you and record your current VAS score.During the study you will be asked to keep track of your daily VAS scores as well as keep a daily diary in order to record a variety of information including times of study medication usage, number of sitz baths, and, when applicable, start/stop times of headaches as well as intensity of headaches.

What treatment will I receive during the APT study?
Study participants will be randomly assigned (like the flip of a coin) to one of two treatment groups:o Group 1 will receive Cellegesic Nitro-glycerin ointment 0.4% to be applied twice a day, every 12 hours.o Group 2 will receive Placebo (ointment that looks like the investigational ointment but contains no active ingredients) to be applied twice a day, every 12 hours.In addition, all participants will be given 2 bottles of paracetemol (generic name for Tylenol®) and will be asked to take 2 tablets (650 mg total) 30 minutes before each ointment application, as a way to help prevent getting a headache (a common side effect of the investigational ointment).Study participants have an equal chance (50%) of being assigned to either Group 1 or Group 2. Neither you nor the study doctor will know which treatment you are receiving. The study is designed this way so researchers can be certain any results are due to the investigational ointment. However, if it becomes necessary for medical reasons, your study doctor is given access to this information.

What are the risks & benefits of the APT study?
As with any medical research study, there are risks associated with your participation. While this investigational ointment is being evaluated, it's possible your condition could become worse or you could experience a side effect. The side effect could be one that is common and known (headache, dizziness, drop in blood pressure), or it could be a side effect not seen before.Of course, it's also possible that you may benefit by participating in the study. At a minimum, you have access to study-related medical care and diagnostic tools used in the treatment of anal fissures.

Who should I contact with more questions?
If you have any questions about the ointment being tested, or this study in general, please speak with the study staff. They are available to answer all of your questions.

About Medical Research Studies:
Pharmaceutical companies must test their investigational medications very carefully before applying to a regulatory agency for permission to make new medications available to the public.

In addition to the pharmaceutical company that sponsors the study, there are two other organizations that are concerned about the study participant's well-being:

1. Each country has a government agency that sets the rules for studying all medications. This agency evaluates these investigational medications to ensure that the marketed drugs are safe and effective.
2. An Ethics Committee (EC) is a group set up to help protect the rights of research participants. An EC is made up of healthcare professionals, scientists, and members of the community, and it is responsible for reviewing a clinical study before it can be approved and start. People on an EC do not work for your study doctor or the drug company, and they are independent from the people sponsoring the study.

A clinical study must follow a detailed plan called a protocol, which explains all study procedures. Additionally, researchers must explain the study to potential study participants and answer any questions they may ask.

Even after enrolling in the study, qualified participants may end their participation at any time and for any reason.

By participating in this research, you may help find answers to benefit others with anal fissures in the future.

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