Major Depressive DisorderPhase 4NCT01070329

A Study in Depression and Associated Painful Physical Symptoms

A Phase 4 study testing Duloxetine in people with Major Depressive Disorder, run by Eli Lilly and Company at 34 sites in 2 countries.

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

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Duloxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 527 participants
Where: 34 sitesin 2 countries
Study dates: Mar 2010to Mar 2011
Phase: Phase 4
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

Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
At least 1 previous episode of depression
Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
Written informed consent

Who cannot join

Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
Women of child-bearing potential who are not using a medically accepted means of contraception
Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
Have any prior history of bipolar disorder, psychosis, or schizophrenia

Show all 25Show fewer

Have an Axis II disorder that would interfere with study compliance
Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment resistant depression
Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
Diagnosis of acute liver injury or severe cirrhosis
Uncontrolled narrow-angle glaucoma
Positive urine drug screen for any substance of abuse
Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
Requires continuous use of analgesics for 6 or more months because of chronic pain
Has pain of a known origin
Meets criteria for fibromyalgia as defined by the American College of Rheumatology
Experiences greater than or equal to 1 migraine headache per week
Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days after discontinuation of study drug
Abnormal thyroid stimulating hormone
Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures

Trial locations and contacts

34 sites in 2 countries.

Country

City, postcode or hospital

34 sites in 2 countries

United States32 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Allentown, Pennsylvania, 18104
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Atlanta, Georgia, 30308
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Beachwood, Ohio, 44122
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Bellevue, Washington, 98007
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Belmont, Massachusetts, 02478
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Boston, Massachusetts, 02135
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Brooklyn, New York, 11235
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Cromwell, Connecticut, 06416
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Evansville, Indiana, 47714
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Florence, Kentucky, 41042
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Fort Lauderdale, Florida, 33319
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Hoffman Estates, Illinois, 60194
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Lake Charles, Louisiana, 70601
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Lincoln, Rhode Island, 02865
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Media, Pennsylvania, 19063
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Memphis, Tennessee, 38119
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Middleton, Wisconsin, 53562
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Oklahoma City, Oklahoma, 73109
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 19107
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Portland, Oregon, 97210
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Richmond, Virginia, 23230
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Rochester, New York, 14618
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Salem, Oregon, 97301
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Sherman Oaks, California, 91403
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Springfield, Illinois, 62711
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Staten Island, New York, 10305
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Toledo, Ohio, 43623
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Toms River, New Jersey, 08755
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Troy, Michigan, 48083
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Wichita Falls, Texas, 76309
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Willingboro, New Jersey, 08046

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Puerto Rico2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Caguas, 00725
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San Juan, 00926

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About this study

Official title: Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms

Conditions: Major Depressive Disorder
Being tested: Duloxetine, Placebo
Medical subject headings: Depressive Disorder, Major

What participants receive

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

DuloxetineDrug
Also called LY248686, Cymbalta
Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
PlaceboDrug
Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.

Study groups in NCT01070329
Study group	Role	What they receive
Duloxetine	Experimental	Not described Receives: Drug: Duloxetine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Measured: Day 1 through 8 weeks
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Measured: Baseline, 8 weeks

Secondary outcomes (8)

Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Measured: Baseline, 8 weeks
Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.
Measured: Baseline, up to 8 weeks
Percentage of Participants Achieving Remission up to Week 8
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).
Measured: Up to 8 weeks
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Measured: Baseline, 4 weeks
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Measured: Baseline, 2 weeks
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Measured: Baseline, 8 weeks
Patient Global Impression of Improvement (PGI-I) Score at Week 8
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.
Measured: 8 weeks
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase
The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a "yes" answer to actual attempt or completed suicide.
Measured: Baseline through 8 weeks

Timeline

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

Mar 2010Mar 2011

First posted18 Feb 2010 (estimated)
Study startMar 2010
Primary completionMar 2011
Study completionMar 2011

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 (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 527 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070329
Sponsor's protocol ID: 13630
Other IDs: F1J-US-HMGU
Status last verified: Jan 2012
First submitted: 16 Feb 2010
Last updated: 13 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
PubMed 12872297
Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.
PubMed 21838410

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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
ClinicalTrials.gov ID: NCT01070329
Acronym / sponsor ID: 13630
Conditions: Major Depressive Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 527 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Posted 13 Feb 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Duloxetine	Experimental	Drug: Duloxetine
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (6 listed)

Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
At least 1 previous episode of depression
Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase

Key exclusion criteria (25 listed)

Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
Women of child-bearing potential who are not using a medically accepted means of contraception
Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study

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
DuloxetineAlso: LY248686, CymbaltaParticipants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.	Drug	Duloxetine
PlaceboParticipants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.	Drug	Placebo

Primary outcome

Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
Time frame: Day 1 through 8 weeks
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
Time frame: Baseline, 8 weeks
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.

8 secondary outcomes

Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
Time frame: Baseline, 8 weeks
Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
Time frame: Baseline, up to 8 weeks
Percentage of Participants Achieving Remission up to Week 8
Time frame: Up to 8 weeks
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
Time frame: Baseline, 4 weeks
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2
Time frame: Baseline, 2 weeks
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
Time frame: Baseline, 8 weeks
Patient Global Impression of Improvement (PGI-I) Score at Week 8
Time frame: 8 weeks
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase
Time frame: Baseline through 8 weeks

Results and safety

Results posted to the registry on 13 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine	261	209
Placebo	266	217

Primary outcome: Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period

Time frame: Day 1 through 8 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Duloxetine n = 255	Placebo n = 265
Value	-1.66 (0.10)	-1.17 (0.10)

Duloxetine vs Placebo: Mean Difference (Final Values): -0.49 (95% CI -0.75 to -0.22), p <0.001, Mixed Models Analysis

Population analysed: All randomized participants with a baseline and at least 1 post-baseline result.

Primary outcome: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8

Time frame: Baseline, 8 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Duloxetine n = 255	Placebo n = 265
Value	-14.96 (0.58)	-10.77 (0.57)

Duloxetine vs Placebo: Mean Difference (Final Values): -4.20 (95% CI -5.77 to -2.62), p <0.001, Mixed Models Analysis

Population analysed: All randomized participants with a baseline and at least 1 post-baseline result.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine	1 of 261 (0.4%)	170 of 261 (65.1%)	Not reported
Placebo	3 of 266 (1.1%)	135 of 266 (50.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12872297Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
Derived from this study: PubMed 21838410Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

34 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine in people with Major Depressive Disorder, run by Eli Lilly and Company at 34 sites in 2 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 6 inclusion and 25 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 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 13 Feb 2012). 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?

Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period (time frame: Day 1 through 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01070329, which also lists 2 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 13 Feb 2012.