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Neuralgia, PostherpeticPhase 2NCT00617461

A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment

A Phase 2 study testing GEn 1200mg/day and GEn 3600mg/day in people with Neuralgia, Postherpetic, run by XenoPort, Inc. at 53 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuralgia, Postherpetic
What is being tested?
GEn 1200mg/day and GEn 3600mg/day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
53 sitesin 2 countries
Study dates
Mar 2008to Jul 2009
Phase
Phase 2
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

  • 18 years or older
  • Documented medical diagnosis of PHN with pain present for at least 3 months from the healing of a herpes zoster rash
  • Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use one a specified highly effective method for avoiding pregnancy.
  • Currently on a stable dose of 1800 mg/day of gabapentin for ≥2 weeks with inadequate response OR
  • Not currently treated with gabapentin, but previously treated with ≥1800 mg/day of gabapentin for 4 weeks or more with inadequate response.
  • Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS
  • Provides written informed consent in accordance with all applicable regulatory requirements

Who cannot join

  • Other chronic pain conditions not associated with PHN. However, the subject will not be excluded if:
  • The pain is located at a different region of the body; and
  • The pain intensity is not greater than the pain intensity of the PHN; and
  • The subject can assess PHN pain independently of other pain
  • Is unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
  • Hepatic impairment defined as ALT or AST > 2x upper limit of normal (ULN), or alkaline phosphatase or bilirubin > 1.5x ULN
Show all 26Show fewer
  • Chronic hepatitis B or C
  • Impaired renal function defined as creatinine clearance <60 mL/min or requiring hemodialysis
  • Corrected QT (QTc) interval ≥ 450 msec or QTc interval ≥480 msec for patients with Bundle Branch Block
  • Uncontrolled hypertension at screen (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg)
  • Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drugs
  • Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn, or, in the investigator's judgment
  • Is considered to be clinically significant and may pose a safety concern, or,
  • Could interfere with the accurate assessment of safety or efficacy, or,
  • Could potentially affect a subject's safety or study outcome
  • Current or chronic history of liver disease (including acute viral hepatitis), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Meets criteria defined by the DSM-IV-TR for a major depressive episode or for active significant psychiatric disorders within last year
  • Depression in remission, with or without antidepressant treatment, may participate, unless stable antidepressant regimen is a prohibited medication
  • Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least three months prior to enrollment
  • History of clinically significant drug or alcohol abuse (DSM-IV-TR) or is unable to refrain from substance abuse throughout the study. Benzodiazepines or atypical benzodiazepines as hypnotic sleep agents permitted.
  • Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device
  • Has participated in a clinical study and was exposed to investigational or non-investigational drug or device:
  • Within preceding month for studies unrelated to PHN, or
  • Within preceding six months for studies related to PHN
  • Treated previously with GEn
  • History of allergic or medically significant adverse reaction to investigational products (including gabapentin) or their excipients, acetaminophen or related compounds

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

United States42 sites

  • GSK Investigational Site

    Austin, Texas, 78756

  • GSK Investigational Site

    Bradenton, Florida, 34209

  • GSK Investigational Site

    Chicago, Illinois, 60617

  • GSK Investigational Site

    Chipley, Florida, 32428

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Gainesville, Florida, 32608

  • GSK Investigational Site

    Greensboro, North Carolina, 27408

  • GSK Investigational Site

    Greensburg, Pennsylvania, 15601

  • GSK Investigational Site

    Houston, Texas, 77028

  • GSK Investigational Site

    Houston, Texas, 77044

  • GSK Investigational Site

    Houston, Texas, 77089

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Lebanon, New Hampshire, 03766

  • GSK Investigational Site

    Longview, Texas, 75605

  • GSK Investigational Site

    Marianna, Florida, 32446

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Medford, Oregon, 97501

  • GSK Investigational Site

    Miami Springs, Florida, 33166

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Naranja, Florida, 33032

  • GSK Investigational Site

    New York, New York, 10004

  • GSK Investigational Site

    Norman, Oklahoma, 73071

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Oxnard, California, 93030

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78238

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    South Miami, Florida, 33143

  • GSK Investigational Site

    St Louis, Missouri, 63117

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Tampa, Florida, 33603

  • GSK Investigational Site

    Tampa, Florida, 33612

  • GSK Investigational Site

    Terre Haute, Indiana, 47802

  • GSK Investigational Site

    Weber City, Virginia, 24290

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Yakima, Washington, 98902

Other trials in United States

Germany11 sites

  • GSK Investigational Site

    Achim, Lower Saxony, 28832

  • GSK Investigational Site

    Berlin, State of Berlin, 10409

  • GSK Investigational Site

    Berlin, State of Berlin, 10435

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44892

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Hattingen, North Rhine-Westphalia, 45525

  • GSK Investigational Site

    Hüttenberg, Hesse, 35625

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Schönau, Baden-Wurttemberg, 69250

  • GSK Investigational Site

    Wiesbaden, Hesse, 65189

Other trials in Germany

About this study

Official title: Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment.

The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.

Read the detailed description

The primary purpose of study PXN110527 was to investigate the efficacy of a high (3600mg/day) dose versus a low (1200mg/day) dose of GEn in subjects with post-herpetic neuralgia (PHN) who have a history of an inadequate response to gabapentin treatment. The study is a cross-over design. Prior to screening subjects are required to have a demonstrated history of an inadequate response (as determined by the investigator) to at least 1800 mg/day of gabapentin. Prior history of treatment with gabapentin includes current treatment at 1800mg/day (2 weeks) or prior treatment with ≥1800mg/day (4 weeks). Subjects could also have been treated with pregabalin monotherapy (150-300mg/day, ≥4 weeks) and had an inadequate response.

Subjects are treated with gabapentin 1800mg/day during the Baseline Period and are randomized if during the Basleline Period they are compliant with gabapentin treatment and have a 24-hour average pain intensity score ≥4.0 based on an 11-point pain intensity numerical rating scale (PI-NRS). Subjects are then randomized to receive gabapentin enacarbil (either 1200mg/day or 3600mg/day in a 1:1 ratio) for Treatment Period 1 (28 days). Followed by a dose of 2400mg/day for 4 days and the alternate fixed dose (either 3600 mg/day or 1200 mg/day) for Treatment Period 2 (28 days).

Being tested
GEn 1200mg/day, GEn 3600mg/day
Keywords
Post-herpetic neuralgia(PHN), Neuropathic pain
Medical subject headings
Neuralgia, Postherpetic, Neuralgia

What participants receive

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

  • GEn 1200mg/dayDrug

    Also called GEn, XP13512/GSK1838262, gabapentin enacarbil

    1200mg/day gabapentin enacarbil

  • GEn 3600mg/dayDrug

    Also called gabapentin enacarbil, GEn, XP13512/GSK1838262

    3600mg/day gabapentin enacarbil

Study groups in NCT00617461
Study groupRoleWhat they receive
GEn 1200mg/dayExperimentalgabapentin enacarbil 1200mg/day, 4 weeks treatment in either the first or second treatment period
Receives: Drug: GEn 1200mg/day
GEn 3600mg/dayExperimentalgabapentin enacarbil 3600mg/day, 4 weeks treatment in either the first or second treatment period
Receives: Drug: GEn 3600mg/day

What is being measured

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

  1. Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data

    Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as end of treatment minus baseline. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  2. Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period

    Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. The by period summary is provided as a sensitivity analysis for the primary analysis.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Secondary outcomes (16)

  1. Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data

    Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  2. Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

    Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  3. Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

    Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  4. Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF

    Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  5. Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

    Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  6. Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

    Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  7. Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

    Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  8. Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period

    Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment score minus the baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  9. Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period

    Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  10. Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data

    The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved" Data are summarized by dose, independent of treatment period.

    Measured: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  11. Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

    The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved". Data are summarized by dose within each treatment period.

    Measured: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  12. Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data

    The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." Data are summarized by dose, independent of treatment period.

    Measured: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  13. Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

    The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." Data are summarized by dose within each treatment period.

    Measured: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  14. Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data

    Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

  15. Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF

    The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where scores range from 0 to 10 (0=no impact to 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. Data are summarized by dose, independent of treatment period.

    Measured: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment)

  16. Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations

    Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as "Full Range." A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured.

    Measured: A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period

Timeline

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

  1. First posted18 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617461
Sponsor's protocol ID
110527
Status last verified
Jan 2013
First submitted
6 Feb 2008
Last updated
22 Jul 2013
Data monitoring committee
No

Publications

  • Harden RN, Freeman R, Rainka M, Zhang L, Bell C, Berges A, Chen C, Graff O, Harding K, Hunter S, Kavanagh S, Schwartzbach C, Warren S, McClung C. A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders. Pain Med. 2013 Dec;14(12):1918-32. doi: 10.1111/pme.12227. Epub 2013 Sep 18.

    PubMed 24102928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GEn 1200mg/day and GEn 3600mg/day in people with Neuralgia, Postherpetic, run by XenoPort, Inc. at 53 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 7 inclusion and 26 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 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 May 2011). 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 Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data (time frame: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)). 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 NCT00617461, 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 22 Jul 2013.

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