Principal Investigator of the PRECISE Trial is Ian Gilron, MD
The Pain Research Group at Queen’s University is conducting a precise trial (Pain RElief Combination Intervention StratEgies) study to determine whether a combination of Pregabalin (Lyrica) and Melatonin relieves Fibromyalgia pain more effectively than either agent alone.
In this study, you will receive 3 different 6 week treatment. During each period, you will take two sets of pills, containing either (1) Pregabalin capsules and filler (Placebo) capsules or (2) Melatonin capsules and filler (Placebo) capsules or (3) Melatonin capsules and Pregabalin capsules. The sequence of treatment periods you receive will be in random order.
For example, you may receive Melatonin and Placebo during the first treatment period, Pregabalin and Placebo during the second period, and Melatonin and Pregabalin in the third period. You will not be told the identity of any of the pills unless there is a medical emergency.
The number of pills will be increased gradually over the first 3-1/2 weeks of each period. As the number of pills increases you may experience side effects such as drowsiness or dizziness as well as possibly a reduction in your pain. Our goal is to achieve the highest possible dose, which causes only minimal side effects. Once that dose is reached, you will continue this over a 7 day period and then gradually decrease the medication doses before moving to the next period. Each treatment period will follow the same pattern.
If, after preliminary screening, it seems appropriate to proceed, you will next be invited to an initial clinic visit. This should take approximately three hours. During the part of the study in which doses are being increased, the study coordinator will call you at least once a week. With each phone call, we will ask you about your pain relief and any side effects you may be experiencing. Throughout the study, you will fill out a daily pain diary where you will indicate daily pain levels.
We require that you maintain your schedule of other pain medications at a constant dose throughout the study. You must inform us prior to any change in your routine medications, and you are required to consult with us prior to starting any new medications. You will also be required to return to the clinic another 3 times for a shorter visit during the 4th or 5th week of each of the 3 treatment periods.
For more information please contact:
Hala Elkerdawy, MD,
Dept. of Anesthesiology
613-549-6666 x 3964
To see the Queen’s University listing of this Clinical Trial go here https://anesthesiology.queensu.ca/research/clinical-studies
To learn about ongoing Clinical Trials and Studies got to https://fibrocanada.ca/en/current/