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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LY3016859 ISA — DRUG
  Administered intravenously (IV)
• LY3556050 ISA — DRUG
  Administered orally
• LY3526318 ISA — DRUG
  Administered orally
• LY3857210 ISA — DRUG
  Administered orally
• Placebo Oral — DRUG
  Placebo administered orally
• Placebo — DRUG
  Placebo administered IV

Study Details

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.

Key Dates

Start date

Jan 30, 2020

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

10,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: LY3016859 Osteoarthritis ISA
  Participants are randomized to receive either active LY3016859 or matching placebo
• Experimental: LY3016859 Diabetic Neuropathic Pain ISA
  Participants are randomized to receive either active LY3016859 or matching placebo
• Experimental: LY3016859 Chronic Back Pain ISA
  Participants are randomized to receive either active LY3016859 or matching placebo
• Experimental: LY3556050 Osteoarthritis ISA
  Participants are randomized to receive either active LY3556050 or matching placebo
• Experimental: LY3556050 Diabetic Neuropathic Pain ISA
  Participants are randomized to receive either active LY3556050 or matching placebo
• Experimental: LY3556050 Chronic Back Pain ISA
  Participants are randomized to receive either active LY3556050 or matching placebo
• Experimental: LY3526318 Osteoarthritis ISA
  Participants are randomized to receive either active LY3526318 or matching placebo
• Experimental: LY3526318 Diabetic Neuropathic Pain ISA
  Participants are randomized to receive either active LY3526318 or matching placebo
• Experimental: LY3526318 Chronic Back Pain ISA
  Participants are randomized to receive either active LY3526318 or matching placebo
• Experimental: LY3857210 Osteoarthritis ISA
  Participants are randomized to receive either active LY3857210 or matching placebo
• Experimental: LY3857210 Diabetic Neuropathic Pain ISA
  Participants are randomized to receive either active LY3857210 or matching placebo
• Experimental: LY3857210 Chronic Back Pain ISA
  Participants are randomized to receive either active LY3857210 or matching placebo

Primary Outcome Measure

Number of Participants Who Were Allocated to Each ISA [ Time Frame: Baseline, Up to Week 8 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (62)

Find similar trials in Birmingham, AL

Related Studies

• Physica System Total Knee Replacement Registry Study
  Recruiting · Limacorporate S.p.a · Rancho Mirage, California
• Surgical Joint Registry MBJRF
  Enrolling By Invitation · Memorial Bone and Joint Research Foundation · Houston, Texas
• Navio Robotic Versus Conventional Total Knee Arthroplasty
  Recruiting · Columbia University · New York, New York
• Outcomes of Low-Impact Exercise Program for People With Ankle, Knee, and/or Hip Pain
  Recruiting · University of Missouri-Columbia · Columbia, Missouri