OsteoarthrosisPhase 3NCT00291499
Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
A Phase 3 study testing Chondroitin 4&6 sulfate (Condrosulf) in people with Osteoarthrosis, run by IBSA Institut Biochimique SA.
Trial summary
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- Chondroitin 4&6 sulfate (Condrosulf)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Aug 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex
- Aged 40 and over
- Outpatients
- Patients fulfilling the American Congress of Rheumatology (ACR) criteria for the reporting of hand OA
- Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs (< 6 month).
- Suffering from regular spontaneous pain on the dominant hand (VAS > or = 40 mm at inclusion time).
Show all 13Show fewer
- Showing a FIHOA score > or = 6.
- Having had at least two painful flares in a finger joint during the previous 12 month.
- Patients who have signed the written informed consent for their participation in the study
- Patients able to understand and follow the protocol.
- Patients with a satisfying health and nutritional status.
- Female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation).
- Female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study.
Who cannot join
- Inflammatory joint disease of other origin
- Septic arthritis
- Chronic inflammatory joint disease
- Previous articular fracture of the concerned articulations
- Use of analgesic therapy for other indications
- Receiving oral corticosteroids
Show all 31Show fewer
- Mono-articular posttraumatic OA of the finger
- Planning surgery of the hands in the following 6 months
- Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:
- Infectious arthritis - Acromegaly
- Ochronosis - Hemachromatosis
- Gout - Wilson's disease
- Chondrocalcinosis - Paget's disease
- Osteochondrosis - Mutation of collagen
- Genetic problems (for ex. hypermobility) - Previous joint fracture
- Arthropathies of different aetiologies - Algodystrophy (M. Sudeck)
- Congenital abnormalities
- Recurrent pseudogout
- Major dysplasias
- Intra-articular injection in a hand joint from less than 3 months
- Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, hyaluronic acid) in the last 3 months
- Articular lavage in the last 3 months
- Treatment with corticoids, by any administration route during the last month
- Patient suffering from frequent asthma crises
- Physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year
- Serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection
- Participation in other clinical trials in the two months preceding the study
- Known or ascertained hypersensitivity to the active ingredient of the tested drug.
- Patients refusing to sign the written informed consent form
- Patients who do not co-operate, not respecting the protocol requirements
- Pregnant or lactating women
About this study
Official title: Clinical Evaluation of Condrosulf 800 mg in the Treatment of Symptomatic OA of the Hand: a 6-month, Double-blind, Placebo Controlled Study
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis.
Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
Read the detailed description
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients.
Primary endpoints:
Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
Secondary endpoints are:
Efficacy evaluation: Global impression of efficacy expressed by the patient and the physician (VAS), Grip strength (measured manometrically); Morning stiffness duration; Consumption of Paracetamol; Tolerability (4-point verbal scale); Adverse Events occurring during the treatment period; Other parameters:Treatment compliance; Biological markers of arthritis
- Conditions
- Osteoarthrosis
- Being tested
- Chondroitin 4&6 sulfate (Condrosulf), Placebo
- Keywords
- symptomatic OA of the hand
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin 4&6 sulfate (Condrosulf)Drug
800 mg/day for 6 months
PlaceboOther
800 mg placebo/day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Chondroitin 4&6 sulfate (Condrosulf) | Active comparator | Not described Receives: Drug: Chondroitin 4&6 sulfate (Condrosulf) |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Spontaneous Pain Intensity of Target Hand
Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand.
Measured: 6 months
Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand
Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score.
Change calculated as difference between the month 6 value and baseline value
Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand
Measured: 6 month
Secondary outcomes (4)
Investigator Global Evaluation on Efficacy
Global impression of the efficacy judged by the Investigators at month 6 by means of a visual analogue scale from 0 (no efficacy) to 100 mm (very good efficacy)
Measured: 6 months
Change in Grip Strength
Grip strength determined on both hands using a Jamar dynamometer.Patients were required to grip the dynamometer handle and squeeze as hard as possible according to their individual pain limits. The right hand grip was measured first, then the left; this procedure was performed 3 times. The mean value of these 3 measurements was recorded.
Change calculated as difference between the month 6 value and baseline value
Measured: 6 months
Change in Morning Stiffness Duration
Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value
Measured: 6 months
Consumption of Paracetamol
Total consumption (between ^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startJun 2005
- Primary completionDec 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for OsteoarthrosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cem Gabay, Prof. Dr., Principal investigator, HUG - Hôpitaux universitaires de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291499
- Sponsor's protocol ID
- 03CH/Ct06
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2006
- Last updated
- 4 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lequesne M. [Symptomatic slow-action anti-arthritic agents: a new therapeutic concept?]. Rev Rhum Ed Fr. 1994 Feb;61(2):75-9. No abstract available. French.
PubMed 7920505Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis Rheum. 2005 Mar;52(3):779-86. doi: 10.1002/art.20867.
PubMed 15751094Uebelhart D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76. doi: 10.1016/j.joca.2004.01.004.
PubMed 15023378Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409-20. doi: 10.2165/00002512-199506050-00007.
PubMed 7647428Howell DS, Altman RD. Cartilage repair and conservation in osteoarthritis. A brief review of some experimental approaches to chondroprotection. Rheum Dis Clin North Am. 1993 Aug;19(3):713-24.
PubMed 8210583Volpi N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers. Osteoarthritis Cartilage. 2002 Oct;10(10):768-77. doi: 10.1053/joca.2002.0824.
PubMed 12359162Conte A, de Bernardi M, Palmieri L, Lualdi P, Mautone G, Ronca G. Metabolic fate of exogenous chondroitin sulfate in man. Arzneimittelforschung. 1991 Jul;41(7):768-72.
PubMed 1772467Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996 Aug;23(8):1385-91.
PubMed 8856618Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21. doi: 10.1016/s1063-4584(98)80006-x.
PubMed 9743814Uebelhart D, Thonar EJ, Zhang J, Williams JM. Protective effect of exogenous chondroitin 4,6-sulfate in the acute degradation of articular cartilage in the rabbit. Osteoarthritis Cartilage. 1998 May;6 Suppl A:6-13. doi: 10.1016/s1063-4584(98)80005-8.
PubMed 9743813Bourgeois P, Chales G, Dehais J, Delcambre B, Kuntz JL, Rozenberg S. Efficacy and tolerability of chondroitin sulfate 1200 mg/day vs chondroitin sulfate 3 x 400 mg/day vs placebo. Osteoarthritis Cartilage. 1998 May;6 Suppl A:25-30. doi: 10.1016/s1063-4584(98)80008-3.
PubMed 9743816Mazieres B, Loyau G, Menkes CJ, Valat JP, Dreiser RL, Charlot J, Masounabe-Puyanne A. [Chondroitin sulfate in the treatment of gonarthrosis and coxarthrosis. 5-months result of a multicenter double-blind controlled prospective study using placebo]. Rev Rhum Mal Osteoartic. 1992 Jul-Sep;59(7-8):466-72. French.
PubMed 1485136Bucsi L, Poor G. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis. Osteoarthritis Cartilage. 1998 May;6 Suppl A:31-6. doi: 10.1016/s1063-4584(98)80009-5.
PubMed 9743817Uebelhart D, Thonar EJ, Delmas PD, Chantraine A, Vignon E. Effects of oral chondroitin sulfate on the progression of knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1998 May;6 Suppl A:39-46. doi: 10.1016/s1063-4584(98)80011-3.
PubMed 9743819Verbruggen G, Goemaere S, Veys EM. Chondroitin sulfate: S/DMOAD (structure/disease modifying anti-osteoarthritis drug) in the treatment of finger joint OA. Osteoarthritis Cartilage. 1998 May;6 Suppl A:37-8. doi: 10.1016/s1063-4584(98)80010-1.
PubMed 9743818
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Condrosulf 800 mg in the Treatment of Symptomatic OA of the Hand: a 6-month, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00291499
- Acronym / sponsor ID
- 03CH/Ct06
- Conditions
- Osteoarthrosis
- Keywords
- symptomatic OA of the hand
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Posted 4 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis.
Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
Detailed description
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients.
Primary endpoints:
Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
Secondary endpoints are:
Efficacy evaluation: Global impression of efficacy expressed by the patient and the physician (VAS), Grip strength (measured manometrically); Morning stiffness duration; Consumption of Paracetamol; Tolerability (4-point verbal scale); Adverse Events occurring during the treatment period; Other parameters:Treatment compliance; Biological markers of arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chondroitin 4&6 sulfate (Condrosulf) | Active comparator | Drug: Chondroitin 4&6 sulfate (Condrosulf) |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients of either sex
- Aged 40 and over
- Outpatients
- Patients fulfilling the American Congress of Rheumatology (ACR) criteria for the reporting of hand OA
- Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs (< 6 month).
Key exclusion criteria (31 listed)
- Inflammatory joint disease of other origin
- Septic arthritis
- Chronic inflammatory joint disease
- Previous articular fracture of the concerned articulations
- Use of analgesic therapy for other indications
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 |
|---|---|---|
| Chondroitin 4&6 sulfate (Condrosulf)800 mg/day for 6 months | Drug | Chondroitin 4&6 sulfate (Condrosulf) |
| Placebo800 mg placebo/day for 6 months | Other | placebo |
Primary outcome
Change in Global Spontaneous Pain Intensity of Target Hand
Time frame: 6 months
Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand.
Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand
Time frame: 6 month
Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score. Change calculated as difference between the month 6 value and baseline value Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand
4 secondary outcomes
Investigator Global Evaluation on Efficacy
Time frame: 6 months
Change in Grip Strength
Time frame: 6 months
Change in Morning Stiffness Duration
Time frame: 6 months
Consumption of Paracetamol
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7920505Lequesne M. [Symptomatic slow-action anti-arthritic agents: a new therapeutic concept?]. Rev Rhum Ed Fr. 1994 Feb;61(2):75-9. No abstract available. French.
- Background: PubMed 15751094Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis Rheum. 2005 Mar;52(3):779-86. doi: 10.1002/art.20867.
- Background: PubMed 15023378Uebelhart D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76. doi: 10.1016/j.joca.2004.01.004.
- Background: PubMed 7647428Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409-20. doi: 10.2165/00002512-199506050-00007.
- Background: PubMed 8210583Howell DS, Altman RD. Cartilage repair and conservation in osteoarthritis. A brief review of some experimental approaches to chondroprotection. Rheum Dis Clin North Am. 1993 Aug;19(3):713-24.
- Background: PubMed 12359162Volpi N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers. Osteoarthritis Cartilage. 2002 Oct;10(10):768-77. doi: 10.1053/joca.2002.0824.
- Background: PubMed 1772467Conte A, de Bernardi M, Palmieri L, Lualdi P, Mautone G, Ronca G. Metabolic fate of exogenous chondroitin sulfate in man. Arzneimittelforschung. 1991 Jul;41(7):768-72.
- Background: PubMed 8856618Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996 Aug;23(8):1385-91.
- Background: PubMed 9743814Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21. doi: 10.1016/s1063-4584(98)80006-x.
- Background: PubMed 9743813Uebelhart D, Thonar EJ, Zhang J, Williams JM. Protective effect of exogenous chondroitin 4,6-sulfate in the acute degradation of articular cartilage in the rabbit. Osteoarthritis Cartilage. 1998 May;6 Suppl A:6-13. doi: 10.1016/s1063-4584(98)80005-8.
- Background: PubMed 9743816Bourgeois P, Chales G, Dehais J, Delcambre B, Kuntz JL, Rozenberg S. Efficacy and tolerability of chondroitin sulfate 1200 mg/day vs chondroitin sulfate 3 x 400 mg/day vs placebo. Osteoarthritis Cartilage. 1998 May;6 Suppl A:25-30. doi: 10.1016/s1063-4584(98)80008-3.
- Background: PubMed 1485136Mazieres B, Loyau G, Menkes CJ, Valat JP, Dreiser RL, Charlot J, Masounabe-Puyanne A. [Chondroitin sulfate in the treatment of gonarthrosis and coxarthrosis. 5-months result of a multicenter double-blind controlled prospective study using placebo]. Rev Rhum Mal Osteoartic. 1992 Jul-Sep;59(7-8):466-72. French.
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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.
Cem Gabay, Prof. Dr. principal investigator
HUG - Hôpitaux universitaires de Genève
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chondroitin 4&6 sulfate (Condrosulf) in people with Osteoarthrosis, run by IBSA Institut Biochimique SA.
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 13 inclusion and 31 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Global Spontaneous Pain Intensity of Target Hand (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00291499, which also lists 19 linked publications.
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 4 Mar 2021.