Osteoarthritis, KneePhase 3NCT00950651
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
A Phase 3 study testing Tramadol HCl Contramid® Once A Day and Tramadol HCl Twice a day in people with Osteoarthritis, Knee and Pain, run by Labopharm Inc..
Trial summary
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- Tramadol HCl Contramid® Once A Day and Tramadol HCl Twice a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Nov 2002
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or Females between the ages of 40 and 75 with a diagnosis of Osteoarthritis (OA) of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
- Knee pain at study enrolment,
- Less than 30 minutes of morning stiffness with or without crepitus on active motion.
- Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within 1 year prior to entry into the study.
- ESR < 40 mm/h
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales total score equal to or more than 150 mm at baseline.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- The Patient signed and dated the (IEC) approved, written, informed consent prior to study participation
Who cannot join
- Known rheumatoid arthritis or any other rheumatoid disease.
- Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations.
- Obesity Class II [body mass index (BMI) equal to or more than 35 kg/m2] (NIH, 2000)
- Major illness that required hospitalisation during the 3 months before commencement of the screening period.
- Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
- Patients who had previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to AEs.
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- Patients who within the 3 weeks prior to study entry took the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or other drugs which reduce seizure threshold.
- Patients who took another investigational agent within the 30 days prior to study entry.
- Patients with a history of seizure disorder other than Infantile Febrile Seizures.
- Patients who were opioid dependent.
- Patients with bowel disease causing malabsorption.
- Patients who were pregnant or lactating or patients of child-bearing potential who were unwilling to utilise a medically approved method of contraception during participation in this clinical trial.
- Patients with significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range.
- Patients with significant renal disease, defined as creatinine clearance <30 mL/min as estimated by the method of Levey et al., 1999.
- Current substance abuse or dependence, other than nicotine.
- Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
- Any other condition that, in the opinion of the investigators, adversely affected the patient's ability to complete the study or its measures.
About this study
Official title: A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee.
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- Tramadol HCl Contramid® Once A Day, Tramadol HCl Twice a day
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HCl Contramid® Once A DayDrug
The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
Tramadol HCl Twice a dayDrug
The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 Tramadol HCl Contramid® Once A Day | Experimental | Not described Receives: Drug: Tramadol HCl Contramid® Once A Day |
| 2 Tramadol HCl Twice a day (SR) | Active comparator | Not described Receives: Drug: Tramadol HCl Twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.
Measured: Baseline to week 12
Secondary outcomes (20)
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Each day before morning dose, patients assessed arthritis pain in worst knee in a diary using a 5-point rating scale ranging from none to severe. A median score was estimated for each patient each week and re-categorized into different degrees of pain (rounding off to the closest integer). Results are of 12th week (day 78-84).
Measured: 12 weeks
Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Stiffness subscale score consists of 2 items each rated on 100mm VAS scale (0mm=no stiffness to 100mm=extreme stiffness). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.
Measured: Baseline to week 12
Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Physical Function subscale score consists of 17 items rated on a 100mm VAS scale (0mm=no difficulty to 100mm=extreme difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change
Measured: Baseline to week 12
Percentage of Change From Baseline in WOMAC Total Score at Week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Each item is rated on a 100mm VAS scale (0mm=no pain/stiffness/difficulty to 100mm=extreme no pain/stiffness/difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Measured: Baseline to week 12
Percentage of Change From Baseline in Current Pain at Week 12
Pain Visual Analogue Scales: Current Pain. Patients indicated their current pain using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change in current pain was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Measured: Baseline to week 12
Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12
Patients indicated their Least Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Measured: Baseline to week 12
Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12
Patients indicated their Worst Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Measured: Baseline to week 12
Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12
Patients indicated their Average Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Measured: Baseline to week 12
Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12
The walking test is a measure of how many seconds it takes the patient to walk a distance of 15 meters. The change from baseline to week 12 was calculated.
Measured: Baseline to week 12
Patient Global Rating of Pain Relief at Week 12
The Patient Global Rating of Pain is a Likert-scale that answers the question: "How do you rate overall pain relief with the drug?" with 4 possible answers that were dichotomized: "very effective", "effective", and "somewhat effective" were summarized to "effective"; "not effective" remained unchanged.
Measured: 12 Weeks
Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Patients were asked: "How have any side effects you may have felt from the drug interfered with day-to-day activities?" with 4 possible answers: "Significantly", "Somewhat", "Minimally", "Not at all".
Measured: 12 weeks
Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Patients who have previously taken tramadol HCl were asked to compare how they compare the current pain relief to the pain relief felt when previously taking tramadol, using a 4-point Likert-scale: "Worse than before", "Same as before", "Somewhat better now", or "Much better now".
Measured: 12 weeks
Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Patients who have previously taken tramadol HCl were asked: "Compared to when you were previously taking tramadol, how have any side effects you have felt during this study interfered with your day-to-day activities?". Possible answers were: "Interfered much less now", "Interfered somewhat less now", "Same as before", "Interfered more now".
Measured: 12 weeks
Physician Overall Rating: Overall Assessment at Week 12
The physician was asked to indicate his overall assessment of the formulation the patient was taking using a 4-point Likert-scale dichotomized for the analysis: Very Effective, Effective, and Somewhat Effective were summarized to Effective; Ineffective remained unchanged.
Measured: 12 weeks
Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12
The physician was asked to indicate the effectiveness of pain control 24 hours after the most recent dose of tramadol using a 4-point Likert-scale, dichotomized for the analysis: Very Effective, Effective, Somewhat Effective were summarized to Effective; Ineffective remained unchanged.
Measured: 12 weeks
Patient Diary: Pain (Between Visit Means) at Week 12
As part of the daily diary for the entire study, patients rated the arthritis pain in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.
Measured: 12 weeks
Patient Diary: Stiffness (Between Visit Means) at Week 12
As part of the daily diary for the entire study, patients rated the stiffness in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.
Measured: 12 weeks
Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12
As part of the daily diary for the entire study, patients rated their ability to get things done with their worst knee using a five-point scale ranging from: 1=No problem to 5=A lot of things didn't get done. Mean scores summarizing the entries of the preceding period were calculated.
Measured: 12 weeks
Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12
As part of the daily diary for the entire study, patients rated their difficulty walking with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.
Measured: 12 weeks
Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12
As part of the daily diary for the entire study, patients rated their difficulty with stairs with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startMar 2002
- Primary completionNov 2002
- Study completionNov 2002
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 (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950651
- Sponsor's protocol ID
- MDT3-001-E1
- Other IDs
- NCT00950651
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2009
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mongin G, Yakusevich V, Kope A, Shostak N, Pikhlak E, Popdan L, Simon J, Navarro C, Fortier L, Robertson S, Bouchard S. Efficacy and Safety Assessment of a Novel Once-Daily Tablet Formulation of Tramadol : A Randomised, Controlled Study versus Twice-Daily Tramadol in Patients with Osteoarthritis of the Knee. Clin Drug Investig. 2004;24(9):545-58. doi: 10.2165/00044011-200424090-00005.
PubMed 17523716
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00950651
- Acronym / sponsor ID
- MDT3-001-E1
- Conditions
- Osteoarthritis, Knee, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Tramadol HCl Contramid® Once A Day | Experimental | Drug: Tramadol HCl Contramid® Once A Day |
| 2 Tramadol HCl Twice a day (SR) | Active comparator | Drug: Tramadol HCl Twice a day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or Females between the ages of 40 and 75 with a diagnosis of Osteoarthritis (OA) of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
- ESR < 40 mm/h
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales total score equal to or more than 150 mm at baseline.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- The Patient signed and dated the (IEC) approved, written, informed consent prior to study participation
Key exclusion criteria (17 listed)
- Known rheumatoid arthritis or any other rheumatoid disease.
- Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations.
- Obesity Class II [body mass index (BMI) equal to or more than 35 kg/m2] (NIH, 2000)
- Major illness that required hospitalisation during the 3 months before commencement of the screening period.
- Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
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 |
|---|---|---|
| Tramadol HCl Contramid® Once A DayThe patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study. | Drug | 1 Tramadol HCl Contramid® Once A Day |
| Tramadol HCl Twice a dayThe patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study. | Drug | 2 Tramadol HCl Twice a day (SR) |
Primary outcome
Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12
Time frame: Baseline to week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.
20 secondary outcomes
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Time frame: 12 weeks
Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in WOMAC Total Score at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in Current Pain at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12
Time frame: Baseline to week 12
Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12
Time frame: Baseline to week 12
Patient Global Rating of Pain Relief at Week 12
Time frame: 12 Weeks
Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Time frame: 12 weeks
Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Time frame: 12 weeks
Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Time frame: 12 weeks
Physician Overall Rating: Overall Assessment at Week 12
Time frame: 12 weeks
Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12
Time frame: 12 weeks
Patient Diary: Pain (Between Visit Means) at Week 12
Time frame: 12 weeks
Patient Diary: Stiffness (Between Visit Means) at Week 12
Time frame: 12 weeks
Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12
Time frame: 12 weeks
Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12
Time frame: 12 weeks
Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17523716Mongin G, Yakusevich V, Kope A, Shostak N, Pikhlak E, Popdan L, Simon J, Navarro C, Fortier L, Robertson S, Bouchard S. Efficacy and Safety Assessment of a Novel Once-Daily Tablet Formulation of Tramadol : A Randomised, Controlled Study versus Twice-Daily Tramadol in Patients with Osteoarthritis of the Knee. Clin Drug Investig. 2004;24(9):545-58. doi: 10.2165/00044011-200424090-00005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol HCl Contramid® Once A Day and Tramadol HCl Twice a day in people with Osteoarthritis, Knee and Pain, run by Labopharm Inc..
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 8 inclusion and 17 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 30 Apr 2012. 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. 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 3 Aug 2009). 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?
Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 (time frame: Baseline to week 12). 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 NCT00950651, which also lists 1 linked publication.
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 30 Apr 2012.