Acute PainPhase 3DAVID lapNCT01904149
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
A Phase 3 study testing Dexketoprofen-single dose, Tramadol-single dose and Dexketoprofen/Tramadol-single dose in people with Acute Pain, run by Menarini Group at 28 sites in 8 countries.
Trial summary
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- Dexketoprofen-single dose, Tramadol-single dose and Dexketoprofen/Tramadol-single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- 28 sitesin 8 countries
- Study dates
- May 2013to May 2014
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 75 years.
- Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
- Patients experiencing pain at rest of at least moderate intensity the day after surgery.
Who cannot join
- Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
- Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
- Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
- Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
- Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
- Breastfeeding women.
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
Poland8 sites
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, 15-224
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, Lublin Voivodeship, 20-081
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship, 20-954
Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
Poznan, 60-535
Wojewodzki Szpital
Przemyśl, 37-700
Specjalistyczny Szpital im. E. Szczeklika
Tarnów, 33-100
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
Warsaw, 00-909
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507
Romania7 sites
Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
Bucharest, 011062
Genesys Fertility Center
Bucharest, 011475
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
Bucharest, 020475
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
Bucharest, 020475
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Spitalul Clinic de Urgenta "Sfantul Pantelimon"
Bucharest, 21623
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
Târgu Mureş, 540136
Hungary4 sites
Bajcsy-Zsilinszky Kórház
Budapest, 1106
University Hospital of Debrecen
Debrecen, H-4012
Fejér megyei Szent György Kórház
Székesfehérvár, 8000
Dr. Bugyi István Kórház
Szentes, H-6600
Latvia2 sites
Juras Medicinas Centre
Riga, LV-1005
Riga East University Hospital Gynecology Clinic
Riga, LV-1038
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, LT-50009
Vilniaus gimdymo namai
Vilnius, LT-02106
Russia2 sites
Moscow Regional Research Institute of Obstetrics and Gynecol
Moscow, 101000
FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA
Saint Petersburg, 194291
Spain2 sites
Complejo Hospitalario Arquitecto Marcide
Ferrol, 15405
Hospital Universitario Arnau de Vilanova
Lleida, Lérida, 25198
About this study
Official title: A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).
Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.
Read the detailed description
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:
- DKP/TRAM followed by DKP/TRAM;
- DKP followed by DKP;
- TRAM followed by TRAM;
- placebo followed by DKP;
- placebo followed by TRAM;
- placebo followed by DKP/TRAM;
The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
- Conditions
- Acute Pain
- Being tested
- Placebo, Dexketoprofen-single dose, Tramadol-single dose, Dexketoprofen/Tramadol-single dose, Dexketoprofen-multiple doses
- Keywords
- Moderate to severe acute pain, Postoperative pain, Abdominal hysterectomy, Analgesics, Dexketoprofen, Tramadol
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo single oral dose (first 8 hours)
Dexketoprofen-single doseDrug
Dexketoprofen single oral dose (first 8 hours)
Tramadol-single doseDrug
Tramadol single oral dose (first 8 hours)
Dexketoprofen/Tramadol-single doseDrug
Dexketoprofen/Tramadol single oral dose (first 8 hours)
Dexketoprofen-multiple dosesDrug
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
Tramadol-multiple dosesDrug
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Dexketoprofen/Tramadol-multiple dosesDrug
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
| Study group | Role | What they receive |
|---|---|---|
| DKP/TRAM followed by DKP/TRAM | Experimental | Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses Receives: Drug: Dexketoprofen/Tramadol-single dose; Drug: Dexketoprofen/Tramadol-multiple doses |
| DKP followed by DKP | Active comparator | Dexketoprofen-single dose followed by Dexketoprofen-multiple doses Receives: Drug: Dexketoprofen-single dose; Drug: Dexketoprofen-multiple doses |
| TRAM followed by TRAM | Active comparator | Tramadol-single dose followed by Tramadol-multiple doses Receives: Drug: Tramadol-single dose; Drug: Tramadol-multiple doses |
| Placebo followed by DKP/TRAM | Other | Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Receives: Drug: Placebo; Drug: Dexketoprofen/Tramadol-multiple doses |
| Placebo followed by DKP | Other | Placebo single dose followed by Dexketoprofen-multiple doses Receives: Drug: Placebo; Drug: Dexketoprofen-multiple doses |
| Placebo followed by TRAM | Other | Placebo single dose followed by Tramadol-multiple doses Receives: Drug: Placebo; Drug: Tramadol-multiple doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Measured: over 8 hours after the first dose
Secondary outcomes (3)
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Measured: over 8 hours after first dose
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.
PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Measured: over 48 hours of the multiple-dose phase
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Measured: over 48 hours of the multiple-dose phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry J McQuay, Professor, Study chair, Balliol College OxfordAndrew Moore, Professor, Study chair, Pain Research & Nuffield Department of Anaesthetics - University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904149
- Sponsor's protocol ID
- DEX-TRA-04
- Other IDs
- 2012-004545-32
- Acronym
- DAVID lap
- Status last verified
- Mar 2016
- First submitted
- 17 Jul 2013
- Last updated
- 1 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fulesdi B, Nizzardo A, Guerrero-Bayon C, Cuadripani S, Piza-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5.
PubMed 26801905
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01904149
- Acronym / sponsor ID
- DAVID lap / DEX-TRA-04
- Conditions
- Acute Pain
- Keywords
- Moderate to severe acute pain, Postoperative pain, Abdominal hysterectomy, Analgesics, Dexketoprofen, Tramadol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).
Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.
Detailed description
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:
- DKP/TRAM followed by DKP/TRAM;
- DKP followed by DKP;
- TRAM followed by TRAM;
- placebo followed by DKP;
- placebo followed by TRAM;
- placebo followed by DKP/TRAM;
The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DKP/TRAM followed by DKP/TRAM | Experimental | Drug: Dexketoprofen/Tramadol-single dose, Drug: Dexketoprofen/Tramadol-multiple dosesDexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses |
| DKP followed by DKP | Active comparator | Drug: Dexketoprofen-single dose, Drug: Dexketoprofen-multiple dosesDexketoprofen-single dose followed by Dexketoprofen-multiple doses |
| TRAM followed by TRAM | Active comparator | Drug: Tramadol-single dose, Drug: Tramadol-multiple dosesTramadol-single dose followed by Tramadol-multiple doses |
| Placebo followed by DKP/TRAM | Other | Drug: Placebo, Drug: Dexketoprofen/Tramadol-multiple dosesPlacebo single dose followed by Dexketoprofen/Tramadol-multiple doses |
| Placebo followed by DKP | Other | Drug: Placebo, Drug: Dexketoprofen-multiple dosesPlacebo single dose followed by Dexketoprofen-multiple doses |
| Placebo followed by TRAM | Other | Drug: Placebo, Drug: Tramadol-multiple dosesPlacebo single dose followed by Tramadol-multiple doses |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 18 to 75 years.
- Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
- Patients experiencing pain at rest of at least moderate intensity the day after surgery.
Key exclusion criteria (6 listed)
- Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
- Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
- Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
- Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
- Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
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 |
|---|---|---|
| PlaceboPlacebo single oral dose (first 8 hours) | Drug | Placebo followed by DKP, Placebo followed by DKP/TRAM, Placebo followed by TRAM |
| Dexketoprofen-single doseDexketoprofen single oral dose (first 8 hours) | Drug | DKP followed by DKP |
| Tramadol-single doseTramadol single oral dose (first 8 hours) | Drug | TRAM followed by TRAM |
| Dexketoprofen/Tramadol-single doseDexketoprofen/Tramadol single oral dose (first 8 hours) | Drug | DKP/TRAM followed by DKP/TRAM |
| Dexketoprofen-multiple dosesDexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses) | Drug | DKP followed by DKP, Placebo followed by DKP |
| Tramadol-multiple dosesTramadol multiple oral doses t.i.d. for 3 days (total 6 doses) | Drug | Placebo followed by TRAM, TRAM followed by TRAM |
| Dexketoprofen/Tramadol-multiple dosesDexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses) | Drug | DKP/TRAM followed by DKP/TRAM, Placebo followed by DKP/TRAM |
Primary outcome
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Time frame: over 8 hours after the first dose
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
3 secondary outcomes
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Time frame: over 8 hours after first dose
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Time frame: over 48 hours of the multiple-dose phase
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
Time frame: over 48 hours of the multiple-dose phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26801905Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fulesdi B, Nizzardo A, Guerrero-Bayon C, Cuadripani S, Piza-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5.
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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.
Henry J McQuay, Professor study chair
Balliol College Oxford
Andrew Moore, Professor study chair
Pain Research & Nuffield Department of Anaesthetics - University of Oxford
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexketoprofen-single dose, Tramadol-single dose and Dexketoprofen/Tramadol-single dose in people with Acute Pain, run by Menarini Group at 28 sites in 8 countries.
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 3 inclusion and 6 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Poland, Romania, Hungary, Latvia, Lithuania and 3 more countries. 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 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 1 Apr 2015). 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?
SPID8 (Sum of Pain Intensity Differences Over 8 Hours) (time frame: over 8 hours after the first dose). 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 NCT01904149, 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 1 Apr 2016.