FibromyalgiaPhase 3NCT01432236
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
A Phase 3 study testing Pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in 4 countries.
Trial summary
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 37 sitesin 4 countries
- Study dates
- Oct 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women of any race or ethnicity who are at least 18 years of age.
- Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.
Who cannot join
- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
- Patients with severe or unstable depression are not eligible.
- Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
- Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
Trial locations and contacts
37 sites in 4 countries.
37 sites in 4 countries
United States26 sites
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
FutureSearch Trials of Neurology
Austin, Texas, 78731
Boston Clinical Trials
Boston, Massachusetts, 02131
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Charlottesville Medical Research
Charlottesville, Virginia, 22911
University of Cincinnati
Cincinnati, Ohio, 45219
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Medical Research and Health Education Foundation, Inc.
Columbus, Georgia, 31909
Radiant Research, Inc.
Columbus, Ohio, 43212
Florida Medical Center & Research, Inc.
Coral Gables, Florida, 33134
Midwest Clinical Research Center
Dayton, Ohio, 45417
Coastal Medical
East Greenwich, Rhode Island, 02818
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Sunstone Medical Research, LLC
Medford, Oregon, 97504
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
SDS Clinical Trials
Orange, California, 92868
Fatigue Consultation Clinic
Salt Lake City, Utah, 84102
Lifetree Clinical Research, LC
Salt Lake City, Utah, 84106
Research Across America
Santa Ana, California, 92705
Meridien Research
Tampa, Florida, 33606
Genova Clinical Research
Tucson, Arizona, 85704
Omega Medical Research
Warwick, Rhode Island, 02886
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Behavioral Medicine Center
Wyomissing, Pennsylvania, 19610
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610
Spain6 sites
Hospital de lˊEsperança
Barcelona, 08024
Instituto Universitario USP Dexeus
Barcelona, 08028
Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
Barcelona, 08034
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital General Universitario de Guadalajara
Guadalajara, 19002
Hospital General Universitario Gregorio Marañon
Madrid, 28028
Canada3 sites
Dr. Alexander McIntyre Inc.
Penticton, British Columbia, V2A 4M4
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1
Canadian Centre for Clinical Trials
Thornhill, Ontario, L4J 1W3
Italy2 sites
Azienda Ospedaliera Luigi Sacco - Polo Universitario
Milan, 20157
Università degli Studi di Roma "La Sapienza"
Roma, 00161
About this study
Official title: A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Pregabalin, placebo
- Keywords
- Pregabalin, Lyrica, depression
- Medical subject headings
- Fibromyalgia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
placeboDrug
placebo capsules twice a day for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group) Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean NRS Pain Score at End of Period.
The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.
Measured: End of each period, at Weeks 6 and 14
Secondary outcomes (13)
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.
This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).
Measured: Baseline
FIQ Score at End of Period.
This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).
Measured: End of each period, at Weeks 6 and 14
Patient Global Impression of Change (PGIC) at the End of Period 1.
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Measured: End of Period 1 at Week 6
Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.
Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.
Measured: Visits 2, 6, and 12
Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.
Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.
Measured: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.
Measured: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.
Measured: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.
Measured: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.
Measured: End of each period, at Weeks 6 and 14
Hospital Anxiety and Depression Scale (HADS) at Baseline.
HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Measured: Baseline
HADS at End of Period.
HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Measured: End of each period, at Weeks 6 and 14
Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Measured: Baseline
EQ-5D Score at End of Period.
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Measured: End of each period, at Weeks 6 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
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 FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432236
- Sponsor's protocol ID
- A0081275
- Other IDs
- 2011-002480-19
- Status last verified
- Oct 2014
- First submitted
- 8 Sep 2011
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bateman L, Sarzi-Puttini P, Burbridge CL, Landen JW, Masters ET, Bhadra Brown P, Scavone JM, Emir B, Vissing RS, Clair AG, Pauer LR. Burden of illness in fibromyalgia patients with comorbid depression. Clin Exp Rheumatol. 2016 Mar-Apr;34(2 Suppl 96):S106-13. Epub 2016 Mar 10.
PubMed 27057659Arnold LM, Sarzi-Puttini P, Arsenault P, Khan T, Bhadra Brown P, Clair A, Scavone JM, Driscoll J, Landen J, Pauer L. Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study. J Rheumatol. 2015 Jul;42(7):1237-44. doi: 10.3899/jrheum.141196. Epub 2015 Jun 1.
PubMed 26034150
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)
- ClinicalTrials.gov ID
- NCT01432236
- Acronym / sponsor ID
- A0081275
- Conditions
- Fibromyalgia
- Keywords
- Pregabalin, Lyrica, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 22 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: PregabalinGroup 1 as Pregabalin vs. Placebo (cross over study in which period one has this group) |
| Placebo | Placebo comparator | Drug: placeboGroup 2 as placebo vs. pregabalin (cross over study in which period two will have this group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women of any race or ethnicity who are at least 18 years of age.
- Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.
Key exclusion criteria (4 listed)
- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
- Patients with severe or unstable depression are not eligible.
- Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
- Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
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 |
|---|---|---|
| PregabalinPregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose | Drug | Pregabalin |
| placeboplacebo capsules twice a day for 14 weeks | Drug | Placebo |
Primary outcome
Mean NRS Pain Score at End of Period.
Time frame: End of each period, at Weeks 6 and 14
The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.
13 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.
Time frame: Baseline
FIQ Score at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Patient Global Impression of Change (PGIC) at the End of Period 1.
Time frame: End of Period 1 at Week 6
Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.
Time frame: Visits 2, 6, and 12
Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Hospital Anxiety and Depression Scale (HADS) at Baseline.
Time frame: Baseline
HADS at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.
Time frame: Baseline
EQ-5D Score at End of Period.
Time frame: End of each period, at Weeks 6 and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27057659Bateman L, Sarzi-Puttini P, Burbridge CL, Landen JW, Masters ET, Bhadra Brown P, Scavone JM, Emir B, Vissing RS, Clair AG, Pauer LR. Burden of illness in fibromyalgia patients with comorbid depression. Clin Exp Rheumatol. 2016 Mar-Apr;34(2 Suppl 96):S106-13. Epub 2016 Mar 10.
- Derived from this study: PubMed 26034150Arnold LM, Sarzi-Puttini P, Arsenault P, Khan T, Bhadra Brown P, Clair A, Scavone JM, Driscoll J, Landen J, Pauer L. Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study. J Rheumatol. 2015 Jul;42(7):1237-44. doi: 10.3899/jrheum.141196. Epub 2015 Jun 1.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in 4 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 2 inclusion and 4 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Spain, Canada, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2014). 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?
Mean NRS Pain Score at End of Period. (time frame: End of each period, at Weeks 6 and 14). 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 NCT01432236, 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 22 Jan 2021.