The Wesley Research Institute

Completed trials

Urology

SOLAR – comparing medication and bladder training to medication alone for patients with symptoms of an overactive bladder
People suffering from overactive bladder syndrome with frequency and urgency symptoms may benefit from drug treatment or non-drug treatment. This international study will involve 700 participants to compare Solifenacin Succinate in a rising dose regimen with simplified bladder training to Solifenacin Succinate alone.

This study will involve:
1. Five consultations over an 18 week period
2. A physical examination and a bladder ultrasound.
3. Completion of a micturition (urination) diary and questionnaires.
Participants will be randomly allocated to one of two different treatment groups receiving either:
- Solifenacin Succinate 5mg with instructions for simplified bladder training
  OR
- Solifenacin Succinate 5mg on its own.

Endocrinology

PHENOMIX – determining the safety and efficacy of a new investigational drug to treat Type 2 Diabetes Mellitus
Individuals with Type 2 Diabetes often experience damage to organs, such as the eyes, kidneys, and nerves. This damage is a direct result of high blood glucose (blood sugar) levels. Controlling rises in blood glucose has been proven to prevent or reduce body organ damage in people with diabetes. The investigational drug, PHX1149, may help to reduce blood glucose levels. The purpose of this study is to evaluate the effects of PHX1149 treatment in participants with Type 2 Diabetes Mellitus in controlling their blood glucose in conjunction with the current treatment, metformin.

This study will involve:
1. Study participants receiving 100, 200 or 400 mg per day of PHX1149 OR a placebo (which has no active ingredient).
2. Study participants taking four oral capsules once daily in the morning.
3. A regular meal schedule should be maintained throughout the study and metformin should also be continued at the same dose as had previously been taken in the four weeks before entering the study (at least 1,500 mg or maximal tolerated dose)
This is a double-blind study, which means neither study participants nor the staff involved in the study know which drug participants are receiving.

Cardiovascular disease

MAIA - to test a new treatment for atrial fibrillation, or irregular heartbeat
This study involves 660 patients from 110 hospitals around the world to test a new treatment for atrial fibrillation (or irregular heartbeat). Atrial fibrillation affects six per cent of people aged over 65 and can lead to heart attacks, stroke and even death.

The trial is for approximately four months and involves:
1. A hospital stay at the start of the treatment with heartbeat monitored constantly for nine hours to verify patients can tolerate the treatment.
2. Study participants are given one of four doses of the new drug OR a placebo (an inactive substance) OR a drug that is readily available on the market and the effects are monitored
3. Study participants being given a small heart monitor to record their heart’s electrical activity at designated times, and if they experience an irregular heart rhythm.
4. Study participants are given three capsules to take each day for three months.
5. Study participants will visit hospital for consultations eight times during the trial and will be required to have blood tests, electrocardiograms and a chest x-ray. To follow-up progress of the condition, questionnaires are to be completed five times during hospital visits.
This is a double-blind study, which means neither study participants nor the staff involved in the study know which drug participants are receiving.

Gastro-intestinal

HOLLISTER – evaluating a new ostomy product

This study aims to evaluate a new ostomy product before it is marketed.

Patients make two visits (including the initial enrolment visit) and receive two follow-up calls from the nurse managing the trial.
The study will test various products for no more than a day at a time, checking for skin redness or irritation.

Respiratory

CAP – studying the efficacy of a new drug to treat pneumonia
250 people in six countries will take part in this study, which aims to identify whether a new drug (EDP-420) is as effective as or more effective than an antibiotic already available by prescription in several countries to treat community acquired pneumonia (CAP)

This drug has already been tested on healthy participants and found to be safe.

Study participants will randomly be assigned to one of two groups and will take either:
1. EDP-420 (the new antibiotic) and a placebo that looks like Ketek® (an antibiotic already available on the market)
  OR
2. Ketek® and a placebo that looks like EDP-420
This is a double-blind study, which means neither study participants nor the staff involved in the study know which drug participants the are receiving.

This study involves FOUR evaluations:
1. Initial screening to determine suitability for the trial including full medical history, physical examination and tests such as chest x-rays, electrocardiograms and blood tests.
2. Three more consultations to further evaluate participants’ health status and receive instructions to take the medication for seven days.
ATTAIN – determining if a new antibiotic is a safe and effective treatment for hospital-acquired pneumonia (HAP)
This study will involve 740 participants in 150 centres to determine if the investigational antibiotic Telavancin is a safe and effective treatment for hospital-acquired pneumonia which is caused by Gram-positive bacteria known as Staphylococcus aureus. Gram-positive bacteria can cause life-threatening illness in healthy patients as well as those who are already ill.

This study will compare Telavancin to Vancomycin, an approved and commonly used antibiotic that is no longer as effective in treating infections caused by Gram-positive bacteria.

The study involves:
1. Initial consultation including taking blood and urine samples, chest x-ray and electrocardiogram (ECG).
2. Drug treatment for seven to 21 days as an inpatient or outpatient.
3. Daily consultation with clinical staff during treatment with further tests on several occasions.
This is a randomised trial whereby patients are given either Telavancin OR Vancomycin. Neither the patients nor any of the staff directly involved in the test know which treatment has been given.