Low Back PainPhase 3NCT02168010
Analgecine for Treatment of Low Back Pain
A Phase 3 study testing Analgecine and Neurotropin in people with Low Back Pain, run by VanWorld Pharmaceutical (Rugao) Company Limited at 7 sites in China.
Trial summary
The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Analgecine and Neurotropin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 participants
- Where
- 7 sitesChina
- Study dates
- Oct 2013to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic low back pain including patients with spinal degeneration, lumbar herniation, lumbar spinal stenosis, and spondylolisthesis
- Pain sustained for 3 or more months after surgical treatment.
- Diagnosis is done by X-ray examination.
- The Visual analysis Scale for Pain is between 3 and 8.
Who cannot join
- Acute low back pain patients.
- Allergy to the tested drug.
- Patients with tuberculosis, tumors, Cushing's syndrome, endocrine diseases, neuropathic diseases, psychiatric problems, and serious deficit in heart / liver /renal functions.
- Patients with pain caused by vascular diseases, stress, or tumors.
- Patients with pregnancy, lactation, or planning to have pregnancy within 3 months after recruitment.
- Alcoholic and drug addicted subjects
Show all 11Show fewer
- Dementia patients who can cooperate with the study activities.
- Patients undergone lumber surgery within 3 months at the date of recruitment.
- Patients who are directly related to the research staff.
- Patients who have been participated in other drug clinical trial in the past 3 months at the date of the recruitment.
- Patients who are not fit for the clinical trial based on the research staff observation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Second Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Shanghai Sixth People's Hosptial
Shanghai, Jiangsu
Zhong Shan Hospital, Fudan University
Shanghai, Jiangsu
No.3 Hospital of Hebei Medical University
Shijiazhuang, Hebei
Tiangjin People's Hospital
Tianjin
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xijing Hospital
Xi'an, Shaanxi
About this study
Official title: Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Patients with chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and 70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4 measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required to score their pain with pain VAS and to have regular blood, urine, and renal/liver function tests. The changes of the pain VAS at day 21 are compared between groups.
- Conditions
- Low Back Pain
- Being tested
- Analgecine, Neurotropin, Placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalgecineDrug
Analgesic drug under test
NeurotropinDrug
Analgesic drug as positive control
PlaceboDrug
Blank tablet as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo) Receives: Drug: Analgecine |
| PosCtrl | Active comparator | PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets). Receives: Drug: Neurotropin |
| Placebo | Placebo comparator | Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Visual Analysis Scale on Pain
Measured: Day 0, 7, 14 and 21
Secondary outcomes (5)
ECG
Measured: Day 0, 21
Routine Hematology Testing
Measured: Day 0, 21
Routine Urine Testing
Measured: Day 0, 21
Renal / Liver function tests
Measured: Day 0, 21
Degree of Improvement of Related Symptoms
Measured: Day 0, 7, 14, 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- VanWorld Pharmaceutical (Rugao) Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Chen-Lung Lin, MD, PhD, Study director, Graduate School of Medicine, Kaohsiung Medical UniversityJian Dong, MD, PhD, Principal investigator, Zhong Shan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168010
- Sponsor's protocol ID
- vw1401
- Status last verified
- Aug 2014
- First submitted
- 17 Jun 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT02168010
- Acronym / sponsor ID
- vw1401
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- VanWorld Pharmaceutical (Rugao) Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Patients with chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and 70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4 measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required to score their pain with pain VAS and to have regular blood, urine, and renal/liver function tests. The changes of the pain VAS at day 21 are compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Drug: AnalgecineTest Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo) |
| PosCtrl | Active comparator | Drug: NeurotropinPosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Group: 2 times a day; 4 tablets / time (4 placebo tablets). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic low back pain including patients with spinal degeneration, lumbar herniation, lumbar spinal stenosis, and spondylolisthesis
- Pain sustained for 3 or more months after surgical treatment.
- Diagnosis is done by X-ray examination.
- The Visual analysis Scale for Pain is between 3 and 8.
Key exclusion criteria (11 listed)
- Acute low back pain patients.
- Allergy to the tested drug.
- Patients with tuberculosis, tumors, Cushing's syndrome, endocrine diseases, neuropathic diseases, psychiatric problems, and serious deficit in heart / liver /renal functions.
- Patients with pain caused by vascular diseases, stress, or tumors.
- Patients with pregnancy, lactation, or planning to have pregnancy within 3 months after recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnalgecineAnalgesic drug under test | Drug | Experiment |
| NeurotropinAnalgesic drug as positive control | Drug | PosCtrl |
| PlaceboBlank tablet as placebo. | Drug | Placebo |
Primary outcome
Change of Visual Analysis Scale on Pain
Time frame: Day 0, 7, 14 and 21
5 secondary outcomes
ECG
Time frame: Day 0, 21
Routine Hematology Testing
Time frame: Day 0, 21
Routine Urine Testing
Time frame: Day 0, 21
Renal / Liver function tests
Time frame: Day 0, 21
Degree of Improvement of Related Symptoms
Time frame: Day 0, 7, 14, 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Chen-Lung Lin, MD, PhD study director
Graduate School of Medicine, Kaohsiung Medical University
Jian Dong, MD, PhD principal investigator
Zhong Shan Hospital, Fudan University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Analgecine and Neurotropin in people with Low Back Pain, run by VanWorld Pharmaceutical (Rugao) Company Limited at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Visual Analysis Scale on Pain (time frame: Day 0, 7, 14 and 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.