NauseaPhase 3NCT00475085

Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

A Phase 3 study testing aprepitant, dexamethasone and granisetron hydrochloride in people with Nausea, run by Joseph Roscoe at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nausea
What is being tested?: aprepitant, dexamethasone and granisetron hydrochloride
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,021 participants
Where: 16 sitesUnited States
Study dates: Dec 2006to Dec 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of cancer and be chemotherapy naive.
Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
Able to understand English

Who cannot join

No symptomatic brain metastases
No concurrent or impending bowel obstruction
Regimens containing liposomal doxorubicin or cisplatin are not allowed.
No concurrent pimozide, terfenadine, astemizole, or cisapride
No concurrent doxorubicin hydrochloride liposome or cisplatin
No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

CCOP - Columbus
Columbus, Ohio, 43215
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
CCOP - North Shore University Hospital
Manhassett, New York, 11030
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
MBCCOP - Gulf Coast
Mobile, Alabama, 36695
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Wichita
Wichita, Kansas, 67214-3882

Other trials in United States

About this study

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Read the detailed description

OBJECTIVES:

Primary

Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center and gender. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.

Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.

PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.

Conditions: Nausea
Being tested: aprepitant, dexamethasone, granisetron hydrochloride, palonosetron hydrochloride, prochlorperazine
Keywords: nausea and vomiting, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, inflammatory breast cancer, male breast cancer
Medical subject headings: Nausea, Vomiting, Breast Neoplasms, Inflammatory Breast Neoplasms, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aprepitantDrug
Also called Emend
Given orally or IV
dexamethasoneDrug
Also called Decadron
Given orally or IV
granisetron hydrochlorideDrug
Also called Kytril
Given orally or IV
palonosetron hydrochlorideDrug
Also called Aloxi
Given orally or IV
prochlorperazineDrug
Also called Compazine
Given orally or IV
placeboDrug
Given orally

Study groups in NCT00475085
Study group	Role	What they receive
Arm I	Active comparator	Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3. Receives: Drug: dexamethasone; Drug: palonosetron hydrochloride; Drug: prochlorperazine; Drug: placebo
Arm II	Experimental	Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3. Receives: Drug: dexamethasone; Drug: granisetron hydrochloride; Drug: prochlorperazine; Drug: placebo
Arm III	Active comparator	Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3. Receives: Drug: aprepitant; Drug: dexamethasone; Drug: palonosetron hydrochloride; Drug: placebo
Arm IV	Experimental	Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3. Receives: Drug: dexamethasone; Drug: palonosetron hydrochloride; Drug: prochlorperazine; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Home Record: Severity of Delayed Nausea
1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse
Measured: average of day 1 afternoon, evening and night, and all of days 2 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Dec 2012

First posted17 May 2007 (estimated)
Study startDec 2006
Primary completionDec 2012

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 NauseaStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,021 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00475085
Sponsor's protocol ID: CDR0000544841
Other IDs: U10CA037420, URCC-U1105
Status last verified: Oct 2015
First submitted: 16 May 2007
Last updated: 10 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Roscoe JA, Heckler CE, Morrow GR, Mohile SG, Dakhil SR, Wade JL, Kuebler JP. Prevention of delayed nausea: a University of Rochester Cancer Center Community Clinical Oncology Program study of patients receiving chemotherapy. J Clin Oncol. 2012 Sep 20;30(27):3389-95. doi: 10.1200/JCO.2011.39.8123. Epub 2012 Aug 20.
PubMed 22915657

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting

All Nausea trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
ClinicalTrials.gov ID: NCT00475085
Acronym / sponsor ID: CDR0000544841
Conditions: Nausea
Keywords: nausea and vomiting, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,021 participants (actual)
Lead sponsor: Joseph RoscoeUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Dec 2006
Primary completion: Dec 2012 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 4 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)

Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.

PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Arm I	Active comparator	Drug: dexamethasone, Drug: palonosetron hydrochloride, Drug: prochlorperazine, Drug: placeboPatients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Arm II	Experimental	Drug: dexamethasone, Drug: granisetron hydrochloride, Drug: prochlorperazine, Drug: placeboPatients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Arm III	Active comparator	Drug: aprepitant, Drug: dexamethasone, Drug: palonosetron hydrochloride, Drug: placeboPatients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
Arm IV	Experimental	Drug: dexamethasone, Drug: palonosetron hydrochloride, Drug: prochlorperazine, Drug: placeboPatients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have a diagnosis of cancer and be chemotherapy naive.
Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.

Key exclusion criteria (6 listed)

No symptomatic brain metastases
No concurrent or impending bowel obstruction
Regimens containing liposomal doxorubicin or cisplatin are not allowed.
No concurrent pimozide, terfenadine, astemizole, or cisapride
No concurrent doxorubicin hydrochloride liposome or cisplatin

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
aprepitantAlso: EmendGiven orally or IV	Drug	Arm III
dexamethasoneAlso: DecadronGiven orally or IV	Drug	Arm I, Arm II, Arm III, Arm IV
granisetron hydrochlorideAlso: KytrilGiven orally or IV	Drug	Arm II
palonosetron hydrochlorideAlso: AloxiGiven orally or IV	Drug	Arm I, Arm III, Arm IV
prochlorperazineAlso: CompazineGiven orally or IV	Drug	Arm I, Arm II, Arm IV
placeboGiven orally	Drug	Arm I, Arm II, Arm III, Arm IV

Primary outcome

Home Record: Severity of Delayed Nausea
Time frame: average of day 1 afternoon, evening and night, and all of days 2 and 3
1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse

Results and safety

Results posted to the registry on 4 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 Palonosetron, Dexamethasone, Compazine	253	235
Arm 2 Granisetron, Dexamethasone, Compazine	254	234
Arm 3 Aprepitant, Palonosetron, Dexamethasone	260	241
Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone	254	234

Primary outcome: Home Record: Severity of Delayed Nausea

Time frame: average of day 1 afternoon, evening and night, and all of days 2 and 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm II n = 234	Arm III n = 241	Arm I n = 234	Arm IV n = 235
Value	1.88 (1.27)	1.65 (1.15)	1.87 (1.20)	1.68 (1.15)

Arm II vs Arm I: Mean Difference (Final Values): -0.013 (95% CI -0.225 to 0.200), p = 0.718, ANOVA
Arm I vs Arm IV: Mean Difference (Final Values): 0.195 (95% CI -0.017 to 0.407), p = 0.010, ANOVA
Arm III vs Arm IV: Mean Difference (Final Values): -0.025 (95% CI -0.236 to 0.186), p = 0.557, ANOVA

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm II	6 of ?	1 of ?	Not reported
Arm III	17 of ?	1 of ?	Not reported
Arm I	16 of ?	0 of ?	Not reported
Arm IV	11 of ?	1 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22915657Roscoe JA, Heckler CE, Morrow GR, Mohile SG, Dakhil SR, Wade JL, Kuebler JP. Prevention of delayed nausea: a University of Rochester Cancer Center Community Clinical Oncology Program study of patients receiving chemotherapy. J Clin Oncol. 2012 Sep 20;30(27):3389-95. doi: 10.1200/JCO.2011.39.8123. Epub 2012 Aug 20.

Related trials for Nausea

Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting

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.

Joseph A. Roscoe, PhD principal investigator

James P. Wilmot Cancer Center

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aprepitant, dexamethasone and granisetron hydrochloride in people with Nausea, run by Joseph Roscoe at 16 sites in United States.

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 7 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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 4 Nov 2013). 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?

Home Record: Severity of Delayed Nausea (time frame: average of day 1 afternoon, evening and night, and all of days 2 and 3). 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 NCT00475085, 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 10 Nov 2015.