Back PainPhase 4NCT00317655
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain
A Phase 4 study testing Glucosamine sulphate, Ginger and Ginger-Avocado-Soya in people with Back Pain, run by Ferrosan AS at 1 site in Denmark.
Trial summary
The main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain. The study is randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Glucosamine sulphate, Ginger and Ginger-Avocado-Soya
- How many people
- 175 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2006to Apr 2007
- Phase
- Phase 4
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic back pain daily or almost daily for at least 3 months prior to inclusion
- Patient classified as I or II according to Quebec Task Force
- No intake of glucosamine sulphate, ginger, or avocado-soya extract during last 3 months
- Fertile women should, at start, have a negative pregnancy test and during test use acceptable prevention methods (p-pills, intrauterine device [IUD], depot gestagen, subdermal implant, hormonal vaginal ring or transdermal depot plaster).
- Anxiolytics, muscle relaxants, physiotherapy, chiropractic treatment, or training should not have been used during last 3 months.
Who cannot join
- Serious disease (eg. heart disease, cancer (within past 5 years), kidney disease, blood diseases, inflammatory diseases (eg. chronic rheumatoid arthritis, fibromyalgia)
- Suspicion that back pain is caused by osteoporosis, other arthritic condition than osteoarthritis, cancer, infection, pain from organ disease or psychosomatic cancer disease.
- Uncontrolled elevated blood pressure, defined as systolic ≥ 160 mm Hg or diastolic ≥ 90 mm Hg.
- VAS measurement at inclusion less than ved 30 mm or over 90 mm.
- Prehistory of ulcer, stomach surgery, or inflammatory bowel disease
- Pain relief medication besides must not be taken during study.
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- Patients in need of non-steroidal anti-inflammatory drugs (NSAIDs), morphine, or similar medication are not eligible. Same is also valid for patients in need of injections or acupuncture.
- Back surgery within 6 months before inclusion or earlier surgery without effect
- "Heart" aspirin (low dose), ulcer medication, or blood thinning medication
- Alcohol abuse
- Depression
- Pregnancy or breastfeeding
- Allergy to crustaceans or known intolerance for glucosamine sulphate, ginger, avocado, soy, or ibuprofen
- Allergy or asthma released by salicylic acid or other arthritis medication (NSAIDs)
- Patient who is seeking pension due to back pain or has other economical interests connected to his/her back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain - a Randomized, Double Blind, Placebo-Controlled Clinical Investigation With Parallel Groups for 3 Months to Enlighten Joint Health
The main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain.
The study is randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks.
- Conditions
- Back Pain
- Being tested
- Glucosamine sulphate, Ginger, Ginger-Avocado-Soya, Ginger-ibuprofen
- Keywords
- back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine sulphateDrug
GingerDrug
Ginger-Avocado-SoyaDrug
Ginger-ibuprofenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
Secondary outcomes (8)
Percentage of responders showing more than 15 mm improvement in pain relief
mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12
Function level according to Roland Morris-questionnaire (23 points)
Patients' Global Impression of Change (pain)
Patients' satisfaction with pain medication
Use of rescue medication
Adverse events profile
Body weight (start and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startApr 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrosan AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Keld Østergaard, MD, PhD, Principal investigator, Slidgigtinstituttet A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317655
- Sponsor's protocol ID
- Jointcare/Fe/1/DK
- Other IDs
- Eudractnr. 2005-002691-15
- Status last verified
- May 2007
- First submitted
- 23 Apr 2006
- Last updated
- 17 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain - a Randomized, Double Blind, Placebo-Controlled Clinical Investigation With Parallel Groups for 3 Months to Enlighten Joint Health
- ClinicalTrials.gov ID
- NCT00317655
- Acronym / sponsor ID
- Jointcare/Fe/1/DK
- Conditions
- Back Pain
- Keywords
- back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ferrosan ASIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 25 Apr 2006 (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 main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain.
The study is randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic back pain daily or almost daily for at least 3 months prior to inclusion
- Patient classified as I or II according to Quebec Task Force
- No intake of glucosamine sulphate, ginger, or avocado-soya extract during last 3 months
- Fertile women should, at start, have a negative pregnancy test and during test use acceptable prevention methods (p-pills, intrauterine device [IUD], depot gestagen, subdermal implant, hormonal vaginal ring or transdermal depot plaster).
- Anxiolytics, muscle relaxants, physiotherapy, chiropractic treatment, or training should not have been used during last 3 months.
Key exclusion criteria (15 listed)
- Serious disease (eg. heart disease, cancer (within past 5 years), kidney disease, blood diseases, inflammatory diseases (eg. chronic rheumatoid arthritis, fibromyalgia)
- Suspicion that back pain is caused by osteoporosis, other arthritic condition than osteoarthritis, cancer, infection, pain from organ disease or psychosomatic cancer disease.
- Uncontrolled elevated blood pressure, defined as systolic ≥ 160 mm Hg or diastolic ≥ 90 mm Hg.
- VAS measurement at inclusion less than ved 30 mm or over 90 mm.
- Prehistory of ulcer, stomach surgery, or inflammatory bowel disease
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 |
|---|---|---|
| Glucosamine sulphate | Drug | – |
| Ginger | Drug | – |
| Ginger-Avocado-Soya | Drug | – |
| Ginger-ibuprofen | Drug | – |
Primary outcome
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
8 secondary outcomes
Percentage of responders showing more than 15 mm improvement in pain relief
mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12
Function level according to Roland Morris-questionnaire (23 points)
Patients' Global Impression of Change (pain)
Patients' satisfaction with pain medication
Use of rescue medication
Adverse events profile
Body weight (start and 12 weeks)
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 17 May 2007.
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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.
Keld Østergaard, MD, PhD principal investigator
Slidgigtinstituttet A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucosamine sulphate, Ginger and Ginger-Avocado-Soya in people with Back Pain, run by Ferrosan AS at 1 site in Denmark.
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 5 inclusion and 15 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 17 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks. 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 17 May 2007.