CompletedPhase 2

Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

United States141 participantsStarted 2012-08

Plain-language summary

This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for safety and efficacy for a period of 6 weeks.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The subject must have a diagnosis of pain due to LSR, with all of the following characteristics:
✓. In the investigator's opinion, the subject's diagnosis of LSR is supported by all of the following at screening:

✕. The subject has:
✕. In the investigator's opinion, the subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately).
✕. The subject has pain in the lower limbs solely upon walking and not at rest.
✕. The subject has undergone surgery for LSR within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for LSR within 4 weeks before screening.
✕. The subject has:
✕. The subject has a history of or currently has any of the following conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety:
✕. The subject has a history of or currently has:
✕. The subject had a malignancy.

Change in weekly average of daily pain scores (PI-NRS)

Timeframe: Baseline to week 6

NCT IDNCT01655849

SponsorZalicus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10