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Disci/Rhus toxicodendron comp

Phase 3

Chronic Low Back Pain | Small molecule | Pain |Pulmonx Corporation|Last Updated: Jul 11, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Disci/Rhus toxicodendron comp · 1 trial · 1 indication

Phase 3 1
NCT00567736Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back PainChronic Low Back Pain
COMPLETED150 Analytics
PHASE3COMPLETED
Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
Chronic Low Back PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual analogue scale (0-100 mm) low back pain
once after 8 weeks

Secondary Endpoints

Back function (back function scale FFbHR)
once at week 8 and 26
visual analogue scale (0-100 mm) low back pain
once after week 26
days with medication
week 4 to 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORDisci/Rhus toxicodendron comp.®
2PLACEBO_COMPARATORplacebo solution
3NO_INTERVENTIONwaiting list group

Interventions

NameTypeDescription
Disci/Rhus toxicodendron comp.®DRUGs.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
placebo solutionDRUGs.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
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Eligibility Criteria

Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female patients, 30 to 75 years * Willingness of following the study protocol * Clinical diagnosis of chronic low back pain * Low back pain since at least 3 months * Average pain intensity of at least 40 mm on VAS (0-100 mm) in the last 7 days * In the last 4 weeks on...

Countries:Germany
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Frequently asked questions about Disci/Rhus toxicodendron comp

What is Disci/Rhus toxicodendron comp used for?

Disci/Rhus toxicodendron comp is an investigational small molecule being studied for the treatment of chronic low back pain. It is currently in Phase 3 clinical development and has not been approved by the FDA.

Who makes Disci/Rhus toxicodendron comp?

Disci/Rhus toxicodendron comp is being developed by Pulmonx Corporation, a company traded on the NASDAQ under the ticker symbol LUNG.

What phase is Disci/Rhus toxicodendron comp in?

Disci/Rhus toxicodendron comp is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for any use.

What clinical trials is Disci/Rhus toxicodendron comp in?

Disci/Rhus toxicodendron comp has one completed Phase 3 clinical trial, NCT00567736, which evaluated its efficacy in patients with chronic low back pain. The trial enrolled 150 participants in Germany and was randomized, double-blind, and placebo-controlled.

Is Disci/Rhus toxicodendron comp the same as Rhus toxicodendron?

Disci/Rhus toxicodendron comp is a combination product that includes Rhus toxicodendron as one of its components. The full name reflects the combination of Disci and Rhus toxicodendron, and it is being studied specifically for chronic low back pain.