Osteoarthritis, KneePhase 2NCT00295490
Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis
A Phase 2 study testing Devil Claw in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Caucasian population. Both forms of osteoarthritis are associated with disability. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Devil Claw
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2004to Jun 2008
- Phase
- Phase 2
- 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 with either a pragmatic diagnosis of osteoarthritis of the knee, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for knee OA1):
- knee pain on most days of the previous month
- morning stiffness of less than 30 minutes duration
- "stiffness" in resting the joint and and are aged over 40 years
- osteoarthritis of the hip, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for hip OA2):
- hip pain on most days of the previous month and at least two of the following 3 features:
Show all 15Show fewer
- ESR < 20mm/hour
- Radiographic femoral or acetabular osteophytes
- Radiographic joint space narrowing (superior, axial and/or medial)
- And are aged over 45 years of age
- The diagnosis of osteoarthritis will be confirmed by X-ray. Only patients who have grade 2 to 4 of the Kellgren and Lawrence scale will be recruited. (The Kellgren and Lawrence scale ranges from grade 0 to grade 4 where grades 0 and 1 represent doubtful osteoarthritic changes and therefore a doubtful diagnosis.)
- Patients who have been on stable medication (conventional or complementary, including nutritional medicine) for the past three months, but are still getting symptoms (incomplete responders)
- Only those patients who record baseline pain scores on the WOMAC scale of at least 20 mm on the VAS for a minimum of 6 out of 7 days monitored during the period from Clinic Visit 1 (screening) and Clinic Visit 2 (baseline)
- Ability to comply with the requirements of the study and to give informed consent
- For women of child-bearing potential: negative pregnancy test
Who cannot join
- Participation in an investigational trial within 30 days prior to enrollment
- Previous treatment with Devil' s Claw within 90 days prior to enrollment
- Patients awaiting a replacement knee or hip joint
- Patients with other conditions that cause pain
- Patients with congenital dislocation of the hip
- Patients who have had operations on their hip due to previous trauma
Show all 16Show fewer
- Patients with severe co-morbidities - including severe cardiac or pulmonary disease and cancer
- Dementia, psychoses, or other significant impairment of mental status that would prohibit sufficient comprehension, provision of informed consent and to allow undertaking of the necessary self-care or toxicity reporting
- Patients taking corticosteroid medication
- Known allergies against any of the ingredients of the treatments
- Patients who would be unable to complete the self assessment forms, or to attend for X-ray and clinical examination
- Patients with other known rheumatic disease such as rheumatoid arthritis
- Patients with the diagnosis gout
- Patients who report a red or hot swollen joint (which is unlikely to be due to OA), and would require further rheumatological assessment
- Patients with conditions known to be contraindicated to the study medication i.e. patients with gastric or duodenal ulcers; gallstones; patients taking drugs for arrhythmias; patients with heart failure
- Patients who are pregnant, trying to become pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust Clinical Research Facility, Southampton General Hospital
Southampton, Hants, SO16 6YD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Two- Centre Study to Evaluate the Efficacy and Safety of Devil's Claw in the Treatment of Knee and Hip Osteoarthritis
Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Caucasian population. Both forms of osteoarthritis are associated with disability. Conventional treatment (analgesics and the use non-steroidal anti-inflammatory, NSAIDS) is prophylactic, aimed at decreasing pain and improving function. However long term use of NSAIDS is associated with a high incidence of adverse events (gastrointestinal tract symptoms). A safer alternative treatment would therefore be beneficial.
Both anecdotal evidence and recent studies have implicated the potential of the herbal remedy Devil's Claw (Harpagophytum procumbens) for the treatment of painful, chronic arthritic type conditions (Ernst and Chrubasik, 2000). Devil's Claw is an extract obtained from the root of the Harpagophytum procumbens plant, a member of the sesame family found in the Kalahari region in South Africa. It has been shown that this herbal remedy has anti-inflammatory and analgesic effects (Baghdikian et al, 1997). Currently Devil's Claw is marketed for use as a supportive treatment of degenerative arthrosis, is not a Medicines Control Agency licensed product and is freely available to the general public in health food stores and pharmacies.
Read more
The objectives of this study are to assess the efficacy, optimum dosage and safety of the herbal remedy Devil's Claw (Harpagophytum) in the treatment of osteoarthritis of the knee and/or hip. The primary objective of this study is to investigate the following three principal questions:
- To compare the efficacy of Devil's Claw with placebo in the treatment of osteoarthritis of the knee and/or hip
- To determine the optimum dose of Devil's Claw and
- To evaluate the safety and tolerability of three doses of Devil's Claw in the treatment of osteoarthritis of the knee/hip and to compare them to placebo There are also a number of secondary research objectives that will also be addressed (see later).
These objectives are based on the following hypotheses :
Hypotheses
- Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain, stiffness and disability aspects on the WOMAC) in chronic osteoarthritis of the knee and/or hip after 16 weeks of treatment, as compared to placebo.
- A dose response effect exists in the treatment of osteoarthritis of the knee/hip by Devil's Claw.
Read the detailed description
STUDY DESIGN: Randomized, placebo-controlled, dose-ranging two-centre study PREPARATIONS FOR INVESTIGATION: Devil's Claw (Allya®)/placebo as tablets
STATISTICAL METHODS:
Analysis on an intention to treat basis.
The following tests will be performed and all statistical significance will be set at p < 0.05:
Primary efficacy analysis: The primary outcome will be the reduction in WOMAC total score from baseline to week 16. The week 16 means for the four treatment groups will be compared using an analysis of covariance taking account of baseline assessments and any demographic differences, age, gender, etc, which are found to be significant. Multiple comparison tests will be used to examine specific differences of initially specified interest, such as the two highest doses of Devil's Claw versus placebo.
Secondary Efficacy Analysis: Similar analyses of covariance will be used to examine treatment group differences at week 16 compared with baseline for WOMAC subscales (pain, stiffness and physical function), and Quality of Life assessments (SF-36). Changes in the subject's well-being and overall global assessment will be compared using appropriate non-parametric tests, e.g. Mann-Whitney test or MacNemar's test. Changes in attitudes and health beliefs to CAM will be assessed using Chi-Squared tests.
Safety Evaluation: Group differences between adverse event reporting will be assessed by descriptive methods.
NUMBER OF PATIENTS:
264 (50 patients in each group, with an expected total of 64 drop-outs) NUMBER OF SITES: 2
TIME SCHEDULE:
Study Start: April 2004 Study End: March 2007 Observation period/patient: 20 weeks
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Devil Claw, Placebo
- Keywords
- double blind randomised controlled trial, phase II, Devil's Claw, osteoarthritis of the knee, osteoarthritis of the hip
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Devil ClawDrug
Also called Harpagophytum procumbens
Dose ranging study so will elucidate dose Frequency is four times daily
PlaceboDrug
Placebo has same dosing freq as for active intervention and for same time period
| Study group | Role | What they receive |
|---|---|---|
| 240mg Devil claw | Experimental | Sub clinical dose if the 3 doses employed Receives: Drug: Devil Claw |
| 960mg Devil Claw | Experimental | Active dose Receives: Drug: Devil Claw |
| 1920 mg Devil claw | Experimental | Active dose Receives: Drug: Devil Claw |
| Placebo | Placebo comparator | Comparator for all active intervention arms Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and Mc Master University OA Index (WOMAC)
WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.
Measured: Baseline, week 8 and week 16
Secondary outcomes (7)
Pain Subscale on Western Ontario and Mc Master University OA Index
Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.
Measured: Baseline, week 8 and week 16
Disability Subscale on The Western Ontario and Mc Master University OA Index
Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.
Measured: baseline, 8 and 16 weeks
Stiffness Subscale on the The Western Ontario and Mc Master University OA Index
Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.
Measured: Baseline, week 8 and week 16
Short Form-36 (SF-36)
Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.
Measured: Baseline, week 8 and week 16
Patient Global Assessment
To assess changes in the subject's well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.
Measured: Baseline, week 8 and week 16
Complementary and Alternative Medicine Beliefs Inventory
Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119
Measured: four monthly
Adverse Event Reporting
To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.
Measured: Baseline and weeks 2,4,6,8,12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startDec 2004
- Primary completionNov 2007
- Study completionJun 2008
Why it stopped: unexpected withdrawal of funding
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.
- Other trials for Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Pascoe Pharmazeutische Praeparate GmbH
- Responsible party
- Principal investigator, Dr Sarah Brien, University of Southampton
- Investigators
- George Lewith, MA MD FRCP, Principal investigator, University of SouthamptonSarah Brien, Bsc Msc PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295490
- Sponsor's protocol ID
- devilclaw1
- Status last verified
- Sep 2011
- First submitted
- 21 Feb 2006
- Last updated
- 12 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-ranging Two- Centre Study to Evaluate the Efficacy and Safety of Devil's Claw in the Treatment of Knee and Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT00295490
- Acronym / sponsor ID
- devilclaw1
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- double blind randomised controlled trial, phase II, Devil's Claw, osteoarthritis of the knee, osteoarthritis of the hip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unexpected withdrawal of funding
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Pascoe Pharmazeutische Praeparate GmbH
- Study start
- Dec 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Feb 2006 (estimated)
- Results
- Posted 9 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Caucasian population. Both forms of osteoarthritis are associated with disability. Conventional treatment (analgesics and the use non-steroidal anti-inflammatory, NSAIDS) is prophylactic, aimed at decreasing pain and improving function. However long term use of NSAIDS is associated with a high incidence of adverse events (gastrointestinal tract symptoms). A safer alternative treatment would therefore be beneficial.
Both anecdotal evidence and recent studies have implicated the potential of the herbal remedy Devil's Claw (Harpagophytum procumbens) for the treatment of painful, chronic arthritic type conditions (Ernst and Chrubasik, 2000). Devil's Claw is an extract obtained from the root of the Harpagophytum procumbens plant, a member of the sesame family found in the Kalahari region in South Africa. It has been shown that this herbal remedy has anti-inflammatory and analgesic effects (Baghdikian et al, 1997). Currently Devil's Claw is marketed for use as a supportive treatment of degenerative arthrosis, is not a Medicines Control Agency licensed product and is freely available to the general public in health food stores and pharmacies.
The objectives of this study are to assess the efficacy, optimum dosage and safety of the herbal remedy Devil's Claw (Harpagophytum) in the treatment of osteoarthritis of the knee and/or hip. The primary objective of this study is to investigate the following three principal questions:
- To compare the efficacy of Devil's Claw with placebo in the treatment of osteoarthritis of the knee and/or hip
- To determine the optimum dose of Devil's Claw and
- To evaluate the safety and tolerability of three doses of Devil's Claw in the treatment of osteoarthritis of the knee/hip and to compare them to placebo There are also a number of secondary research objectives that will also be addressed (see later).
These objectives are based on the following hypotheses :
Hypotheses
- Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain, stiffness and disability aspects on the WOMAC) in chronic osteoarthritis of the knee and/or hip after 16 weeks of treatment, as compared to placebo.
- A dose response effect exists in the treatment of osteoarthritis of the knee/hip by Devil's Claw.
Detailed description
STUDY DESIGN: Randomized, placebo-controlled, dose-ranging two-centre study PREPARATIONS FOR INVESTIGATION: Devil's Claw (Allya®)/placebo as tablets
STATISTICAL METHODS:
Analysis on an intention to treat basis.
The following tests will be performed and all statistical significance will be set at p < 0.05:
Primary efficacy analysis: The primary outcome will be the reduction in WOMAC total score from baseline to week 16. The week 16 means for the four treatment groups will be compared using an analysis of covariance taking account of baseline assessments and any demographic differences, age, gender, etc, which are found to be significant. Multiple comparison tests will be used to examine specific differences of initially specified interest, such as the two highest doses of Devil's Claw versus placebo.
Secondary Efficacy Analysis: Similar analyses of covariance will be used to examine treatment group differences at week 16 compared with baseline for WOMAC subscales (pain, stiffness and physical function), and Quality of Life assessments (SF-36). Changes in the subject's well-being and overall global assessment will be compared using appropriate non-parametric tests, e.g. Mann-Whitney test or MacNemar's test. Changes in attitudes and health beliefs to CAM will be assessed using Chi-Squared tests.
Safety Evaluation: Group differences between adverse event reporting will be assessed by descriptive methods.
NUMBER OF PATIENTS:
264 (50 patients in each group, with an expected total of 64 drop-outs) NUMBER OF SITES: 2
TIME SCHEDULE:
Study Start: April 2004 Study End: March 2007 Observation period/patient: 20 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 240mg Devil claw | Experimental | Drug: Devil ClawSub clinical dose if the 3 doses employed |
| 960mg Devil Claw | Experimental | Drug: Devil ClawActive dose |
| 1920 mg Devil claw | Experimental | Drug: Devil ClawActive dose |
| Placebo | Placebo comparator | Drug: PlaceboComparator for all active intervention arms |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with either a pragmatic diagnosis of osteoarthritis of the knee, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for knee OA1):
- osteoarthritis of the hip, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for hip OA2):
- The diagnosis of osteoarthritis will be confirmed by X-ray. Only patients who have grade 2 to 4 of the Kellgren and Lawrence scale will be recruited. (The Kellgren and Lawrence scale ranges from grade 0 to grade 4 where grades 0 and 1 represent doubtful osteoarthritic changes and therefore a doubtful diagnosis.)
- Patients who have been on stable medication (conventional or complementary, including nutritional medicine) for the past three months, but are still getting symptoms (incomplete responders)
- Only those patients who record baseline pain scores on the WOMAC scale of at least 20 mm on the VAS for a minimum of 6 out of 7 days monitored during the period from Clinic Visit 1 (screening) and Clinic Visit 2 (baseline)
Key exclusion criteria (16 listed)
- Participation in an investigational trial within 30 days prior to enrollment
- Previous treatment with Devil' s Claw within 90 days prior to enrollment
- Patients awaiting a replacement knee or hip joint
- Patients with other conditions that cause pain
- Patients with congenital dislocation of the hip
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 |
|---|---|---|
| Devil ClawAlso: Harpagophytum procumbensDose ranging study so will elucidate dose Frequency is four times daily | Drug | 1920 mg Devil claw, 240mg Devil claw, 960mg Devil Claw |
| PlaceboPlacebo has same dosing freq as for active intervention and for same time period | Drug | Placebo |
Primary outcome
Western Ontario and Mc Master University OA Index (WOMAC)
Time frame: Baseline, week 8 and week 16
WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.
7 secondary outcomes
Pain Subscale on Western Ontario and Mc Master University OA Index
Time frame: Baseline, week 8 and week 16
Disability Subscale on The Western Ontario and Mc Master University OA Index
Time frame: baseline, 8 and 16 weeks
Stiffness Subscale on the The Western Ontario and Mc Master University OA Index
Time frame: Baseline, week 8 and week 16
Short Form-36 (SF-36)
Time frame: Baseline, week 8 and week 16
Patient Global Assessment
Time frame: Baseline, week 8 and week 16
Complementary and Alternative Medicine Beliefs Inventory
Time frame: four monthly
Adverse Event Reporting
Time frame: Baseline and weeks 2,4,6,8,12 and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Lewith, MA MD FRCP principal investigator
University of Southampton
Sarah Brien, Bsc Msc PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Devil Claw in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University of Southampton at 1 site in United Kingdom.
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 15 inclusion and 16 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: stopped early, as of the sponsor's last update on 12 Sep 2011. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Sep 2011). 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?
Western Ontario and Mc Master University OA Index (WOMAC) (time frame: Baseline, week 8 and week 16). 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 12 Sep 2011.