Phase 3 N=221 Randomized Quadruple-blind Treatment

Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT01049373 ↗

Enrolled (actual)

221

Serious AEs

5.9%

Results posted

Sep 2012

Primary outcome: Primary: Change in FFbH-R Between Screening and Week 15 — 8.8; 4.1 units on a scale — p=0.0426

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: HDC (Drug); Placebo solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pascoe Pharmazeutische Praeparate GmbH
Primary completion: May 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in FFbH-R Between Screening and Week 15	8.8; 4.1	0.0426 sig
SECONDARY Change in FFbH-R Between Screening and 2 Weeks	3.9; 0.6	0.0757
SECONDARY Change in Pain Score (SES), Subscale "Sensoric Pain"	-5.4; -3.9	0.04443 sig
SECONDARY Change in Pain Score (SES), Subscale "Sensoric Pain"	-5.4; -3.9	0.04443 sig
SECONDARY Change in Strength of Pain (Visual Analog Scale VAS)	—	—
SECONDARY Change in Strength of Pain (Visual Analog Scale VAS)	—	—
SECONDARY Change in State of Health (BF-S)	—	—
SECONDARY Change in State of Health (BF-S)	—	—
SECONDARY Change in Oswestry Score	—	—
SECONDARY Change in Oswestry Score	—	—
SECONDARY Change in Short Form Health Survey 12 Items (SF-12)	—	—
SECONDARY Change in Short Form Health Survey 12 Items (SF-12) Ment	—	—
SECONDARY Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)	—	—
SECONDARY Amount of Analgesics Used	—	—
SECONDARY Number of Days With Incapability to Work	—	—
SECONDARY Number of ADRs	8; 7	—

Summary

To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period.

Eligibility Criteria

Inclusion Criteria

Male and female patients
Aged 18 - 75 years
Chronic low-back pain lasting at least for 6 months
Hanover functional ability questionnaire (FFbH-R) score less than 70%
At least one of the following diagnoses:
Chronic lumbar ischialgia with or without radicular radiation
Chronic degenerative lumbar syndrome
Spondylarthrosis
Chronic facet syndrome
Lumbago with protrusion of the intervertebral disc
Lumbar radiculopathy
Lumbar and other intervertebral disc impairments with radiculopathy
Back pain at different locations of the spine
Written, informed consent

Exclusion Criteria

Participation in another clinical trial/GCP-trial within 30 days prior to screening
Participation in this trial in an earlier time
Treatment with lymphdiaral basistropfen within 3 month prior to enrolment
Pregnancy and lactation
Non-compliance
Incapability to understand the sense of the study
Abuse of analgesics, opiates or other drugs
Chronic pain that are as strong as or even stronger than the pain caused by the low-back and that need to be treated with analgesics
Malign diseases
Pathological neurological states
Epilepsy
Operation of the spine within 3 month prior to enrolment
Fractures of the spine
Bechterew's disease
Alcohol abuse
Consuming diseases
Cachexia
Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc
Catheterisation or CT-controlled intra-articular injection in the lumbar region
Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general
Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01049373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.