FibromyalgiaPhase 2NCT00689052
Pramipexole ER vs. Placebo in Fibromyalgia
A Phase 2 study testing pramipexole ER in people with Fibromyalgia, run by Boehringer Ingelheim at 42 sites in United States.
Trial summary
The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- pramipexole ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 42 sitesUnited States
- Study dates
- Jul 2008to Nov 2008
- 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
- Male and female outpatients greater than or equal to 18 years of age
- Meet criteria for primary fibromyalgia as defined by the American College of Rheumatology (ACR): widespread aching pain in all four quadrants of the body and axial skeleton for greater than 3 months duration and greater than or equal to 11 of 18 tender points under digital palpitation examination with an approximate force of 4 kilograms per centimeters squared (kg/cm2)
- Pain score of greater than or equal to 4 (scored once at screening and as a weekly mean at baseline) on the 11-point Likert pain scale with 0 = no pain and 10 = worst possible pain
- Score of greater than or equal to 4 (= moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening and at baseline
- All females of child-bearing potential must test negative for pregnancy at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and two years postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for one month following the last dose of study medication. Examples of reliable methods include: use of hormonal contraception (oral, injectable, or subcutaneous), double-barrier method, abstinence, partner with vasectomy, or hormonal intrauterine devices
- Educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator
- Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol
Who cannot join
- Employees of Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study)
- Have received treatment within 30 days prior to screening with a drug that has not received regulatory approval for any indication
- Have previously completed or withdrawn from this study or any other study investigating pramipexole.
- Any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Have any primary anxiety disorder within the past year as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Have any Diagnosis of Statistical Manual of Mental Diseases, 4th Edition (DSM-IV) Axis II disorder that would interfere with protocol compliance
Show all 24Show fewer
- Medium or high risk of suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI)
- History of substance abuse/dependence within the past year, excluding nicotine and caffeine
- A positive urine drug screen for any substance of abuse or excluded medication
- Women who are pregnant or breast-feeding
- Have pain symptoms related to traumatic injury that will interfere with the interpretation of outcome measures
- Patients with regional pain syndromes, multiple surgeries or failed back surgery syndrome
- A confirmed or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease
- Abnormal C-Reactive Protein, Anti-Nuclear Antibody (ANA), Rheumatoid factor, or Thyroid Stimulating Hormone (TSH)
- Any serious or unstable medical or psychiatric condition or clinically significant abnormalities in labs at screening that would lead to hospitalization during the course of the study or otherwise compromise study participation
- Have uncontrolled seizures
- Taking any prohibited medications that cannot be discontinued at screening
- Patients who are treatment-refractory or whose response may be compromised by disability compensation issues
- Patients with frequent or severe allergic reactions to multiple medications
- Prior or current treatment with pramipexole
- Clinically significant renal disease
- Current or previous diagnosis of malignant melanoma
- Clinically relevant ophthalmopathy
- Documented sleep apnea
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
248.637.01008 Boehringer Ingelheim Investigational Site
Albany, New York
248.637.01024 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
248.637.01032 Boehringer Ingelheim Investigational Site
Arcadia, California
248.637.01007 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
248.637.01019 Boehringer Ingelheim Investigational Site
Austin, Texas
248.637.01017 Boehringer Ingelheim Investigational Site
Billings, Montana
248.637.01009 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
248.637.01025 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
248.637.01028 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.637.01004 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
248.637.01038 Boehringer Ingelheim Investigational Site
Columbus, Ohio
248.637.01031 Boehringer Ingelheim Investigational Site
Danbury, Connecticut
248.637.01035 Boehringer Ingelheim Investigational Site
DeLand, Florida
248.637.01039 Boehringer Ingelheim Investigational Site
Duncansville, Pennsylvania
248.637.01042 Boehringer Ingelheim Investigational Site
Englewood, Colorado
248.637.01026 Boehringer Ingelheim Investigational Site
Fargo, North Dakota
248.637.01020 Boehringer Ingelheim Investigational Site
Flowood, Mississippi
248.637.01023 Boehringer Ingelheim Investigational Site
Fort Myers, Florida
248.637.01034 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas
248.637.01012 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
248.637.01014 Boehringer Ingelheim Investigational Site
Lansing, Michigan
248.637.01010 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
248.637.01044 Boehringer Ingelheim Investigational Site
Los Angeles, California
248.637.01046 Boehringer Ingelheim Investigational Site
Medford, Oregon
248.637.01002 Boehringer Ingelheim Investigational Site
New York, New York
248.637.01016 Boehringer Ingelheim Investigational Site
Newton, Massachusetts
248.637.01003 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
248.637.01047 Boehringer Ingelheim Investigational Site
Orlando, Florida
248.637.01043 Boehringer Ingelheim Investigational Site
Palm Beach Gardens, Florida
248.637.01033 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
248.637.01018 Boehringer Ingelheim Investigational Site
Picayune, Mississippi
248.637.01006 Boehringer Ingelheim Investigational Site
Portland, Oregon
248.637.01021 Boehringer Ingelheim Investigational Site
Renton, Washington
248.637.01041 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
248.637.01037 Boehringer Ingelheim Investigational Site
San Antonio, Texas
248.637.01036 Boehringer Ingelheim Investigational Site
Santa Ana, California
248.637.01029 Boehringer Ingelheim Investigational Site
Seattle, Washington
248.637.01011 Boehringer Ingelheim Investigational Site
Spokane, Washington
248.637.01040 Boehringer Ingelheim Investigational Site
Sunrise, Florida
248.637.01027 Boehringer Ingelheim Investigational Site
Tampa, Florida
248.637.01045 Boehringer Ingelheim Investigational Site
Tucson, Arizona
248.637.01015 Boehringer Ingelheim Investigational Site
Warwick, Rhode Island
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Titration Efficacy and Safety Study of Pramipexole ER (0.75 to 4.5 mg) Administered Orally Once Daily Versus Placebo Over a 16-week Maintenance Phase in Patients Diagnosed With Fibromyalgia, as Assessed by the American College of Rheumatology (ACR) Criteria Followed by a 24-week Open-label Extension Phase
The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.
The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.
- Conditions
- Fibromyalgia
- Being tested
- pramipexole ER, placebo
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramipexole ERDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole ER | Experimental | 0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening Receives: Drug: pramipexole ER |
| Placebo | Placebo comparator | Placebo tablets, once daily in the evening Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale
The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)
Measured: Baseline and Week 29
Secondary outcomes (12)
The Proportion of Patients "Very Much Improved" or "Much Improved" on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale
PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment.
The score ranges from 1 = very much improved to 7 = very much worse
Measured: Week 29 (at the end of the maintenance phase)
The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).
The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .
SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).
Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1
Measured: Baseline and Week 29
The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale
11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .
Measured: Baseline and Week 29
Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)
FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week.
The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact
Measured: Baseline and Week 29
Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).
The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms
Measured: Baseline and Week 29
The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).
The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .
SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).
Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1
Measured: Baseline and Week 29
Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)
The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient's health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.
Measured: Baseline and Week 29
Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)
The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .
Measured: Baseline and Week 29
Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)
The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.
Measured: Baseline and Week 29
Clinical Global Impression of Severity (CGI-S Scores)
Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
Measured: Baseline and Week 29
Frequency of Rescue Medication for Pain
Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.
Measured: Week 29
Change From Baseline in Mean Tender Point Threshold
The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.
Measured: Baseline and Week 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008
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.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689052
- Sponsor's protocol ID
- 248.637
- Status last verified
- May 2014
- First submitted
- 29 May 2008
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Titration Efficacy and Safety Study of Pramipexole ER (0.75 to 4.5 mg) Administered Orally Once Daily Versus Placebo Over a 16-week Maintenance Phase in Patients Diagnosed With Fibromyalgia, as Assessed by the American College of Rheumatology (ACR) Criteria Followed by a 24-week Open-label Extension Phase
- ClinicalTrials.gov ID
- NCT00689052
- Acronym / sponsor ID
- 248.637
- Conditions
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 25 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.
The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole ER | Experimental | Drug: pramipexole ER0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening |
| Placebo | Placebo comparator | Drug: placeboPlacebo tablets, once daily in the evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female outpatients greater than or equal to 18 years of age
- Meet criteria for primary fibromyalgia as defined by the American College of Rheumatology (ACR): widespread aching pain in all four quadrants of the body and axial skeleton for greater than 3 months duration and greater than or equal to 11 of 18 tender points under digital palpitation examination with an approximate force of 4 kilograms per centimeters squared (kg/cm2)
- Pain score of greater than or equal to 4 (scored once at screening and as a weekly mean at baseline) on the 11-point Likert pain scale with 0 = no pain and 10 = worst possible pain
- Score of greater than or equal to 4 (= moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening and at baseline
- All females of child-bearing potential must test negative for pregnancy at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and two years postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for one month following the last dose of study medication. Examples of reliable methods include: use of hormonal contraception (oral, injectable, or subcutaneous), double-barrier method, abstinence, partner with vasectomy, or hormonal intrauterine devices
Key exclusion criteria (24 listed)
- Employees of Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study)
- Have received treatment within 30 days prior to screening with a drug that has not received regulatory approval for any indication
- Have previously completed or withdrawn from this study or any other study investigating pramipexole.
- Any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Have any primary anxiety disorder within the past year as assessed by the Mini International Neuropsychiatric Interview (MINI)
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 |
|---|---|---|
| pramipexole ER | Drug | Pramipexole ER |
| placebo | Drug | Placebo |
Primary outcome
The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale
Time frame: Baseline and Week 29
The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)
12 secondary outcomes
The Proportion of Patients "Very Much Improved" or "Much Improved" on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale
Time frame: Week 29 (at the end of the maintenance phase)
The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).
Time frame: Baseline and Week 29
The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale
Time frame: Baseline and Week 29
Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)
Time frame: Baseline and Week 29
Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).
Time frame: Baseline and Week 29
The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).
Time frame: Baseline and Week 29
Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)
Time frame: Baseline and Week 29
Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)
Time frame: Baseline and Week 29
Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)
Time frame: Baseline and Week 29
Clinical Global Impression of Severity (CGI-S Scores)
Time frame: Baseline and Week 29
Frequency of Rescue Medication for Pain
Time frame: Week 29
Change From Baseline in Mean Tender Point Threshold
Time frame: Baseline and Week 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pramipexole ER in people with Fibromyalgia, run by Boehringer Ingelheim at 42 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 7 inclusion and 24 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: stopped early, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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. 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 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 25 Nov 2009). 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?
The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale (time frame: Baseline and Week 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.