Medication AdherenceECO-PHILNCT02604901
Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications
A study testing Screening and Brief Intervention (BI) and Pill Box (PB) in people with Medication Adherence, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a reminder device (Pillbox), and the combination of the two on adherence in adult patients who filled a prescription for oral medications to treat diabetes or hyperlipidemia. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Screening and Brief Intervention (BI) and Pill Box (PB)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,091 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Jul 2014
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients taking oral medications for diabetes or hyperlipidemia
- 30-85 years of age
- Comfortable speaking in English
- Not institutionalized
- Not diagnosed with psychosis or dementia.
- Needed at least one prescription refill with the index medication picked up within 14 days of the index prescription fill
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rite Aid® Corporation
Marietta, Georgia, 30060
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a reminder device (Pillbox), and the combination of the two on adherence in adult patients who filled a prescription for oral medications to treat diabetes or hyperlipidemia.
Read the detailed description
Patients diagnosed with chronic diseases often fail to follow their prescribed medication regimens, (16355071,19954264,16732693,23111664) which accounts for up to 290 billion dollars per year in unnecessary medical costs, largely because medication nonadherence increases their risk of disease progression, hospitalization, and premature death.(16355071, 23373139, 23032359) A number of studies have investigated ways to improve medication adherence; (18425859, 18537843) however, few studies on interventions have demonstrated large improvements in adherence and few have used scientifically rigorous study methods such as randomized controlled trials (RCTs).(24422970) A recent systematic review identified a need for adherence interventions and suggested the use of factorial designs in RCTs to study multiple interventions and combinations within large patient populations.(24422970)
This study used a factorial-designed, four-armed, RCT to examine the impact of three pharmacy-based interventions versus standard care on improving medication adherence and health outcomes in patients with diabetes and hyperlipidemia. The three interventions used in this study were a behavioral intervention, a pillbox weekly reminder, and the combination of the two.
Pillboxes (PB) used in this study had compartments for each day (7X1) and for participants taking multiple medications, sub-compartments for each medication per day (7X4).
The behavioral intervention, called Screening and Brief Intervention (SBI or BI), consisted of a short 2-5 minute conversation between the patient and the provider aimed to encourage modification in the patient's health behavior. While BI has primarily been used to address unhealthy alcohol use in patients (11), the researchers hypothesized that this patient-centered approach can be particularly useful for improving medication adherence in chronically ill patients. In this study, motivational interviewing counseling principles were used for motivating patients to take more active roles in self-managing their health. Motivational interviewing can take many forms, however, in this study, the BIs used a schema of motivational interviewing originally developed by the principal investigator titled POLAR*S™ .
The specific aims of this research study included testing the impact of three community pharmacy intervention for adult patients with diabetes or hyperlipidemia on: (1) medication adherence; (2) biologic outcomes associated with medication adherence; (3) self-reported health and psychosocial status; and (4) pharmacists' impressions on how BI could be scalable to community pharmacy settings.
- Conditions
- Medication Adherence
- Being tested
- Screening and Brief Intervention (BI), Pill Box (PB)
- Keywords
- medication adherence, community pharmacies, screening and brief intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and Brief Intervention (BI)Behavioural
Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR*S (BI). BI was considered an active intervention method.
Pill Box (PB)Behavioural
Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.
| Study group | Role | What they receive |
|---|---|---|
| Screening and Brief Intervention (BI) | Experimental | Screening and Brief Intervention (BI) at initial prescription fill and at each additional refill. Receives: Behavioral: Screening and Brief Intervention (BI) |
| Pill Box (PB) | Experimental | Pill Box (PB) and information about their medications at the initial fill and at each additional refill. Receives: Behavioral: Pill Box (PB) |
| Brief Intervention + Pill Box (BI+PB) | Experimental | Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill. Receives: Behavioral: Screening and Brief Intervention (BI); Behavioral: Pill Box (PB) |
| Standard Care (SC) | No intervention | The Standard Care (SC) arm administered traditional dispensing and counseling by Rite Aid® pharmacists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia.
Medication adherence was measured as a Proportion of Days Covered (PDC) by calculating (at the patient level) the denominator as the number of days between the first fill of the medication during a measurement period and the end of the measurement period and the numerator is calculated as the number of days covered by prescription fill date and days of supply. For each patient, the PDC was calculated at baseline and 9-months. The baseline PDC was compared to that at 9-months.
Measured: At baseline and nine-months post-enrollment into the study.
Secondary outcomes (7)
Change in triglyerceride levels from baseline to 6- and 9-months.
Triglyeride levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months.
Measured: At baseline, six months and nine-months post-enrollment into the study.
Change in cholesterol levels from baseline to 6- and 9-months.
Cholesterol levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months.
Measured: At baseline, six months and nine-months post-enrollment into the study.
Change in high-density lipoprotein (HDL) levels from baseline to 6- and 9-months.
High-density lipoprotein (HDL) levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months.
Measured: At baseline, six months and nine-months post-enrollment into the study.
Change in low-density lipoprotein (LDL) levels from baseline to 6- and 9-months.
Low-density lipoprotein (LDL) levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months.
Measured: At baseline, six months and nine-months post-enrollment into the study.
Change in glycated hemoglobin (HbA1c) levels from baseline to 6- and 9-months.
Glycated hemoglobin (HbA1c) levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months.
Measured: At baseline, six months and nine-months post-enrollment into the study.
Change in self-reported healthcare utilization, using a study-designed standardized questionnaire, from baseline to 9-months.
Self-reported healthcare utilization information was collected upon enrollment during the baseline interview using a standardized questionnaire developed bv the PI for the study. These interviews were repeated for the 9-month follow-up period.
Measured: At baseline and nine-months post-enrollment into the study.
Change in self-reported psychosocial status, using a study-designed standardized questionnaire, from baseline to 9-months.
Self-reported psychosocial status information was collected upon enrollment during the baseline interview using a standardized questionnaire developed bv the PI for the study. These interviews were repeated for the 9-month follow-up period.
Measured: At baseline and nine-months post-enrollment into the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Rite Aid Corp., RTI International, Pharmacy Quality Alliance, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jan Pringle, University of Pittsburgh
- Investigators
- Janice L Pringle, PhD, Principal investigator, University of PittsburghNewell McElwee, PharmD, MSPH, Study chair, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604901
- Sponsor's protocol ID
- ECOPHIL
- Acronym
- ECO-PHIL
- Status last verified
- Nov 2015
- First submitted
- 5 Nov 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. doi: 10.18553/jmcp.2009.15.9.728.
PubMed 19954264Vik SA, Hogan DB, Patten SB, Johnson JA, Romonko-Slack L, Maxwell CJ. Medication nonadherence and subsequent risk of hospitalisation and mortality among older adults. Drugs Aging. 2006;23(4):345-56. doi: 10.2165/00002512-200623040-00007.
PubMed 16732693Traynor K. Poor medication adherence remains a problem. Am J Health Syst Pharm. 2012 Nov 1;69(21):1850. doi: 10.2146/news120074. No abstract available.
PubMed 23111664Stefanacci RG, Guerin S. Why medication adherence matters to patients, payers, providers. Manag Care. 2013 Jan;22(1):37-9. No abstract available.
PubMed 23373139Williams J, Steers WN, Ettner SL, Mangione CM, Duru OK. Cost-related nonadherence by medication type among Medicare Part D beneficiaries with diabetes. Med Care. 2013 Feb;51(2):193-8. doi: 10.1097/MLR.0b013e318270dc52.
PubMed 23032359Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
PubMed 18425859Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs. 2008 Jul;63(2):132-43. doi: 10.1111/j.1365-2648.2008.04656.x.
PubMed 18537843Viswanathan M, Golin CE, Jones CD, Ashok M, Blalock S, Wines RC, Coker-Schwimmer EJ, Grodensky CA, Rosen DL, Yuen A, Sista P, Lohr KN. Closing the quality gap: revisiting the state of the science (vol. 4: medication adherence interventions: comparative effectiveness). Evid Rep Technol Assess (Full Rep). 2012 Sep;(208.4):1-685.
PubMed 24422970Babor TF, Kadden RM. Screening and interventions for alcohol and drug problems in medical settings: what works? J Trauma. 2005 Sep;59(3 Suppl):S80-7; discussion S94-100. doi: 10.1097/01.ta.0000174664.88603.21.
PubMed 16355071
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications
- ClinicalTrials.gov ID
- NCT02604901
- Acronym / sponsor ID
- ECO-PHIL / ECOPHIL
- Conditions
- Medication Adherence
- Keywords
- medication adherence, community pharmacies, screening and brief intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,091 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Rite Aid Corp., RTI International, Pharmacy Quality Alliance, Merck Sharp & Dohme LLC
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Nov 2015 (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.
The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a reminder device (Pillbox), and the combination of the two on adherence in adult patients who filled a prescription for oral medications to treat diabetes or hyperlipidemia.
Detailed description
Patients diagnosed with chronic diseases often fail to follow their prescribed medication regimens, (16355071,19954264,16732693,23111664) which accounts for up to 290 billion dollars per year in unnecessary medical costs, largely because medication nonadherence increases their risk of disease progression, hospitalization, and premature death.(16355071, 23373139, 23032359) A number of studies have investigated ways to improve medication adherence; (18425859, 18537843) however, few studies on interventions have demonstrated large improvements in adherence and few have used scientifically rigorous study methods such as randomized controlled trials (RCTs).(24422970) A recent systematic review identified a need for adherence interventions and suggested the use of factorial designs in RCTs to study multiple interventions and combinations within large patient populations.(24422970)
This study used a factorial-designed, four-armed, RCT to examine the impact of three pharmacy-based interventions versus standard care on improving medication adherence and health outcomes in patients with diabetes and hyperlipidemia. The three interventions used in this study were a behavioral intervention, a pillbox weekly reminder, and the combination of the two.
Pillboxes (PB) used in this study had compartments for each day (7X1) and for participants taking multiple medications, sub-compartments for each medication per day (7X4).
The behavioral intervention, called Screening and Brief Intervention (SBI or BI), consisted of a short 2-5 minute conversation between the patient and the provider aimed to encourage modification in the patient's health behavior. While BI has primarily been used to address unhealthy alcohol use in patients (11), the researchers hypothesized that this patient-centered approach can be particularly useful for improving medication adherence in chronically ill patients. In this study, motivational interviewing counseling principles were used for motivating patients to take more active roles in self-managing their health. Motivational interviewing can take many forms, however, in this study, the BIs used a schema of motivational interviewing originally developed by the principal investigator titled POLAR*S™ .
The specific aims of this research study included testing the impact of three community pharmacy intervention for adult patients with diabetes or hyperlipidemia on: (1) medication adherence; (2) biologic outcomes associated with medication adherence; (3) self-reported health and psychosocial status; and (4) pharmacists' impressions on how BI could be scalable to community pharmacy settings.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Screening and Brief Intervention (BI) | Experimental | Behavioral: Screening and Brief Intervention (BI)Screening and Brief Intervention (BI) at initial prescription fill and at each additional refill. |
| Pill Box (PB) | Experimental | Behavioral: Pill Box (PB)Pill Box (PB) and information about their medications at the initial fill and at each additional refill. |
| Brief Intervention + Pill Box (BI+PB) | Experimental | Behavioral: Screening and Brief Intervention (BI), Behavioral: Pill Box (PB)Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill. |
| Standard Care (SC) | No intervention | –The Standard Care (SC) arm administered traditional dispensing and counseling by Rite Aid® pharmacists. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients taking oral medications for diabetes or hyperlipidemia
- 30-85 years of age
- Comfortable speaking in English
- Not institutionalized
- Not diagnosed with psychosis or dementia.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Screening and Brief Intervention (BI)Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR*S (BI). BI was considered an active intervention method. | Behavioural | Brief Intervention + Pill Box (BI+PB), Screening and Brief Intervention (BI) |
| Pill Box (PB)Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method. | Behavioural | Brief Intervention + Pill Box (BI+PB), Pill Box (PB) |
Primary outcome
Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia.
Time frame: At baseline and nine-months post-enrollment into the study.
Medication adherence was measured as a Proportion of Days Covered (PDC) by calculating (at the patient level) the denominator as the number of days between the first fill of the medication during a measurement period and the end of the measurement period and the numerator is calculated as the number of days covered by prescription fill date and days of supply. For each patient, the PDC was calculated at baseline and 9-months. The baseline PDC was compared to that at 9-months.
7 secondary outcomes
Change in triglyerceride levels from baseline to 6- and 9-months.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
Change in cholesterol levels from baseline to 6- and 9-months.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
Change in high-density lipoprotein (HDL) levels from baseline to 6- and 9-months.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
Change in low-density lipoprotein (LDL) levels from baseline to 6- and 9-months.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
Change in glycated hemoglobin (HbA1c) levels from baseline to 6- and 9-months.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
Change in self-reported healthcare utilization, using a study-designed standardized questionnaire, from baseline to 9-months.
Time frame: At baseline and nine-months post-enrollment into the study.
Change in self-reported psychosocial status, using a study-designed standardized questionnaire, from baseline to 9-months.
Time frame: At baseline and nine-months post-enrollment into the study.
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 16 Nov 2015.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Background: PubMed 19954264Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. doi: 10.18553/jmcp.2009.15.9.728.
- Background: PubMed 16732693Vik SA, Hogan DB, Patten SB, Johnson JA, Romonko-Slack L, Maxwell CJ. Medication nonadherence and subsequent risk of hospitalisation and mortality among older adults. Drugs Aging. 2006;23(4):345-56. doi: 10.2165/00002512-200623040-00007.
- Background: PubMed 23111664Traynor K. Poor medication adherence remains a problem. Am J Health Syst Pharm. 2012 Nov 1;69(21):1850. doi: 10.2146/news120074. No abstract available.
- Background: PubMed 23373139Stefanacci RG, Guerin S. Why medication adherence matters to patients, payers, providers. Manag Care. 2013 Jan;22(1):37-9. No abstract available.
- Background: PubMed 23032359Williams J, Steers WN, Ettner SL, Mangione CM, Duru OK. Cost-related nonadherence by medication type among Medicare Part D beneficiaries with diabetes. Med Care. 2013 Feb;51(2):193-8. doi: 10.1097/MLR.0b013e318270dc52.
- Background: PubMed 18425859Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
- Background: PubMed 18537843Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs. 2008 Jul;63(2):132-43. doi: 10.1111/j.1365-2648.2008.04656.x.
- Background: PubMed 24422970Viswanathan M, Golin CE, Jones CD, Ashok M, Blalock S, Wines RC, Coker-Schwimmer EJ, Grodensky CA, Rosen DL, Yuen A, Sista P, Lohr KN. Closing the quality gap: revisiting the state of the science (vol. 4: medication adherence interventions: comparative effectiveness). Evid Rep Technol Assess (Full Rep). 2012 Sep;(208.4):1-685.
- Background: PubMed 16355071Babor TF, Kadden RM. Screening and interventions for alcohol and drug problems in medical settings: what works? J Trauma. 2005 Sep;59(3 Suppl):S80-7; discussion S94-100. doi: 10.1097/01.ta.0000174664.88603.21.
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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.
Janice L Pringle, PhD principal investigator
University of Pittsburgh
Newell McElwee, PharmD, MSPH study chair
Merck Sharp & Dohme LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and Brief Intervention (BI) and Pill Box (PB) in people with Medication Adherence, run by University of Pittsburgh at 2 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 6 inclusion and 1 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 16 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 2 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.
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?
Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia. (time frame: At baseline and nine-months post-enrollment into the study.). 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 NCT02604901, which also lists 10 linked publications.
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 16 Nov 2015.