RECRUITING

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

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Conditions

Osteoarthritis, KneeDiabetic Neuropathic PainChronic Low-back Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Quick Facts

Study Start:2020-01-30
Study Completion:2027-04-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05986292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening.
  2. * have a history of daily pain for at least 12 weeks based on participant report or medical history
  3. * have a value of ≤30 on the pain catastrophizing scale
  4. * have a body mass index \<40 kilogram/square meter (kg/m²) (inclusive)
  5. * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
  6. * are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study
  1. * have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
  2. * have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)
  3. * have surgery planned during the study for any reason, related or not to the disease state under evaluation.
  4. * have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
  5. * have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
  6. * have fibromyalgia
  7. * have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
  8. * have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
  9. * have a positive human immunodeficiency virus (HIV) test result at screening
  10. * have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Simon Williamson Clinic
Birmingham, Alabama, 35211
United States
Synexus Clinical Research - Glendale
Glendale, Arizona, 85306
United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020
United States
Arizona Research Center
Phoenix, Arizona, 85053
United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281
United States
Irvine Clinical Research
Irvine, California, 92614
United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
United States
Artemis Institute for Clinical Research
Riverside, California, 92503
United States
Artemis Institute for Clinical Research
San Diego, California, 92103
United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180
United States
Accel Research Sites- Clinical Research Unit
DeLand, Florida, 32720
United States
Encore Research Group- Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Suncoast Research Group
Miami, Florida, 33135
United States
New Horizon Research Center
Miami, Florida, 33165
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Synexus Clinical Research - St. Petersburg
Pinellas Park, Florida, 33781
United States
Martin E. Hale M.D., P.A.
Plantation, Florida, 33317
United States
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Synexus Clinical Research
Chicago, Illinois, 60602
United States
Northwestern University
Chicago, Illinois, 60611
United States
Cotton O'Neil Clinical Research Center - Central Office
Topeka, Kansas, 66606
United States
DelRicht Research
New Orleans, Louisiana, 70115
United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
United States
StudyMetrix Research
Saint Peters, Missouri, 63303
United States
Clinvest Research LLC
Springfield, Missouri, 65807
United States
Synexus Clinical Research US, Inc.
Omaha, Nebraska, 68144
United States
Rochester Clinical Research, LLC
Rochester, New York, 14609
United States
PharmQuest
Greensboro, North Carolina, 27408
United States
Lillestol Research
Fargo, North Dakota, 58104
United States
Synexus - Cincinnati
Cincinnati, Ohio, 45236
United States
Aventiv Research Inc
Columbus, Ohio, 43213
United States
META Medical Research Institute
Dayton, Ohio, 45432
United States
DelRicht Research
Tulsa, Oklahoma, 74133
United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, 19610
United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
United States
FutureSearch Trials of Neurology
Austin, Texas, 78731
United States
Synexus
Dallas, Texas, 75234
United States
Cedar Health Research
Dallas, Texas, 75251
United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229
United States
SYNEXUS
Murray, Utah, 84123
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Rainier Clinical Research Center
Renton, Washington, 98057
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-30
Study Completion Date2027-04-25

Study Record Updates

Study Start Date2020-01-30
Study Completion Date2027-04-25

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee
  • Diabetic Neuropathic Pain
  • Chronic Low-back Pain