You are here

Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Lifetree Clinical Research
Salt Lake City, Utah, 84106 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Chronic moderate to severe non-cancer pain that has been treated with opioid
analgesics for at least three months (with stabilized pain control and stabilized dose
for 28 days prior to enrollment).

- Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.

- Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following
naloxone administration during the Naloxone Challenge.

If female and able to become pregnant, must use an approved method of birth control.

- Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the
Investigator to be in generally good health at screening based upon the results of a
medical history, physical examination, laboratory profile, and 12 lead
electrocardiogram (ECG).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Female who is pregnant or breastfeeding.

- Patient has a known allergy or history of significant adverse reaction to morphine,
other opioids, naltrexone, acetaminophen, or related compounds.

- Patient is receiving systemic chemotherapy, has an active malignancy of any type, or
has been diagnosed with cancer within the 5 years prior to screening (excluding
squamous or basal cell carcinoma of the skin).

- History of, or ongoing, alcohol or drug abuse.

- Patient has made a donation of blood or has had a significant blood loss within 30
days prior to screening.

NCT01100437
Pfizer
Terminated
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Chronic Pain, Hip Osteoarthritis, Knee Osteoarthritis
NCT02528188
All Genders
18+
Years
Multiple Sites
Chronic Pain
NCT01100437
All Genders
21+
Years
Salt Lake City, Utah
Osteoarthritis, Chronic Pain
NCT00420992
All Genders
21+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now