The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.
The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
10,000
Administered intravenously (IV)
Administered orally
Administered orally
Administered orally
Placebo administered orally
Placebo administered IV
Central Research Associates
Birmingham, Alabama, United States
NOT_YET_RECRUITINGSimon Williamson Clinic
Birmingham, Alabama, United States
COMPLETEDSynexus Clinical Research - Glendale
Glendale, Arizona, United States
COMPLETEDCentral Phoenix Medical Clinic
Phoenix, Arizona, United States
RECRUITINGNumber of Participants Who Were Allocated to Each ISA
Time frame: Baseline, Up to Week 8
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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Arizona Research Center
Phoenix, Arizona, United States
RECRUITINGAlliance for Multispecialty Research, LLC
Tempe, Arizona, United States
COMPLETEDIrvine Clinical Research
Irvine, California, United States
COMPLETEDDesert Oasis Healthcare Medical Group
Palm Springs, California, United States
NOT_YET_RECRUITINGArtemis Institute for Clinical Research
Riverside, California, United States
RECRUITINGArtemis Institute for Clinical Research
San Diego, California, United States
RECRUITING...and 54 more locations