MalnutritionPhase 4NCT01831310
Nutrition for Colorectal Cancer Patients and Neutrophil Functions
A Phase 4 study testing Standard (Kabiven), Standard-Glutamine and Standard-Omega 3 fatty acid in people with Malnutrition and Colorectal Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Hypercatabolism and immune suppression are frequently seen in patients with malignancy. Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Malnutrition, Colorectal Cancer
- What is being tested?
- Standard (Kabiven), Standard-Glutamine and Standard-Omega 3 fatty acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer patients who were included study were between 50 and 70 years old
Who cannot join
- preoperatively suffered from serious comorbid chronic disease and received chemotherapy and radiotherapy
- immunosuppressive and /or immunomodulator drugs in last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine
Kocaeli, 41300
About this study
Official title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
Hypercatabolism and immune suppression are frequently seen in patients with malignancy. Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response. In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa. There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.
Read the detailed description
Purpose Hypercatabolism and immune suppression are frequently seen in patients with malignancy.Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response.In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa.There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.
Condition Intervention Phase Malnutrition Colorectal Cancer Dietary Supplement: Immunonutrition Phase 4
Study Type: Interventional Study Design: Prevention, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, N/A
Official Title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
Primary Outcome Measure: Title: neutrophil functions Time Frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay Description: For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
Secondary Outcome Measures: Title: Length of stay Time Frame: Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.
Description: For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital stay)
Actual Enrollment: 36 Study Start Date: January 2007 Actual Study Completion Date: January 2008 Actual Primary Completion Date: January 2008
Arms Assigned Interventions Active Comparator: Control an isocaloric and iso-nitrogenous standard parenteral nutrition
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Experimental: Standard parenteral-glutamine (S-D) alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Experimental: Standard-Omega-3 fatty acid (S-O) Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Experimental: Standard-glutamine-omega 3 (S-D-O) ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
- Conditions
- Malnutrition, Colorectal Cancer
- Being tested
- Standard (Kabiven), Standard-Glutamine, Standard-Omega 3 fatty acid, Standard-glutamine-omega 3
- Keywords
- Colorectal cancer, nutrition, neutrophil phagocytosis, neutrophil adhesivity, glutamine, omega 3 fatty acids
- Medical subject headings
- Malnutrition, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard (Kabiven)Dietary supplement
Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Standard-GlutamineDietary supplement
Also called Standard (Kabiven)-Glutamine (Dipeptiven)
Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. it was 0.3-0.4 g/kg/day for glutamine dipeptide (Dipeptiven) supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Standard-Omega 3 fatty acidDietary supplement
Also called Standard (Kabiven)-Omega 3 fatty acid(Omegaven)
Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven)supplementation was 0.1-0.2 g/kg /day. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Standard-glutamine-omega 3Dietary supplement
Also called Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven)
Parenteral nutrition (kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven) supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide (dipeptiven)supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
| Study group | Role | What they receive |
|---|---|---|
| Control (standard) (Kabiven) | Active comparator | an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven) Receives: Dietary Supplement: Standard (Kabiven) |
| Standard parenteral-glutamine (S-D) | Experimental | alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8), Receives: Dietary Supplement: Standard-Glutamine |
| Standard-Omega-3 fatty acid (S-O) | Experimental | Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8) Receives: Dietary Supplement: Standard-Omega 3 fatty acid |
| Standard-glutamine-omega 3 (S-D-O) | Experimental | ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10). Receives: Dietary Supplement: Standard-glutamine-omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil functions
For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
Measured: perioperative,postoperative third and seventh days for change in first seven days of hospital stay
Secondary outcomes (1)
Length of stay
For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital stay)
Measured: Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuh Zafer Cantürk, Kocaeli University
- Investigators
- Mustafa Dulger, Professor, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831310
- Sponsor's protocol ID
- Canturkz1
- Other IDs
- KOUNutrition1
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT01831310
- Acronym / sponsor ID
- Canturkz1
- Conditions
- Malnutrition, Colorectal Cancer
- Keywords
- Colorectal cancer, nutrition, neutrophil phagocytosis, neutrophil adhesivity, glutamine, omega 3 fatty acids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypercatabolism and immune suppression are frequently seen in patients with malignancy. Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response. In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa. There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.
Detailed description
Purpose Hypercatabolism and immune suppression are frequently seen in patients with malignancy.Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response.In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa.There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.
Condition Intervention Phase Malnutrition Colorectal Cancer Dietary Supplement: Immunonutrition Phase 4
Study Type: Interventional Study Design: Prevention, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, N/A
Official Title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
Primary Outcome Measure: Title: neutrophil functions Time Frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay Description: For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
Secondary Outcome Measures: Title: Length of stay Time Frame: Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.
Description: For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital stay)
Actual Enrollment: 36 Study Start Date: January 2007 Actual Study Completion Date: January 2008 Actual Primary Completion Date: January 2008
Arms Assigned Interventions Active Comparator: Control an isocaloric and iso-nitrogenous standard parenteral nutrition
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Experimental: Standard parenteral-glutamine (S-D) alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Experimental: Standard-Omega-3 fatty acid (S-O) Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Experimental: Standard-glutamine-omega 3 (S-D-O) ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).
Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (standard) (Kabiven) | Active comparator | Dietary Supplement: Standard (Kabiven)an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven) |
| Standard parenteral-glutamine (S-D) | Experimental | Dietary Supplement: Standard-Glutaminealanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8), |
| Standard-Omega-3 fatty acid (S-O) | Experimental | Dietary Supplement: Standard-Omega 3 fatty acidOmega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8) |
| Standard-glutamine-omega 3 (S-D-O) | Experimental | Dietary Supplement: Standard-glutamine-omega 3ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal cancer patients who were included study were between 50 and 70 years old
Key exclusion criteria (2 listed)
- preoperatively suffered from serious comorbid chronic disease and received chemotherapy and radiotherapy
- immunosuppressive and /or immunomodulator drugs in last 6 months
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 |
|---|---|---|
| Standard (Kabiven)Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line | Dietary supplement | Control (standard) (Kabiven) |
| Standard-GlutamineAlso: Standard (Kabiven)-Glutamine (Dipeptiven)Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. it was 0.3-0.4 g/kg/day for glutamine dipeptide (Dipeptiven) supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line | Dietary supplement | Standard parenteral-glutamine (S-D) |
| Standard-Omega 3 fatty acidAlso: Standard (Kabiven)-Omega 3 fatty acid(Omegaven)Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven)supplementation was 0.1-0.2 g/kg /day. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line | Dietary supplement | Standard-Omega-3 fatty acid (S-O) |
| Standard-glutamine-omega 3Also: Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven)Parenteral nutrition (kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven) supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide (dipeptiven)supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line | Dietary supplement | Standard-glutamine-omega 3 (S-D-O) |
Primary outcome
neutrophil functions
Time frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay
For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
1 secondary outcome
Length of stay
Time frame: Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
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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.
Mustafa Dulger, Professor study chair
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard (Kabiven), Standard-Glutamine and Standard-Omega 3 fatty acid in people with Malnutrition and Colorectal Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 15 Apr 2013. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
neutrophil functions (time frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay). 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 15 Apr 2013.