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    Summary
    EudraCT Number:2011-003266-32
    Sponsor's Protocol Code Number:A0081269
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2011-003266-32
    A.3Full title of the trial
    A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CROSS-OVER EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY AND PAIN ON WALKING (PROTOCOL A0081269)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test pregabalin in the treatment of patients with painful diabetic peripheral neuropathy and pain on walking
    A.4.1Sponsor's protocol code numberA0081269
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc. 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800718 1021
    B.5.5Fax number001303739 1119
    B.5.6E-mailclinicatrials.govcallcenter@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lyrica®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePregabalin
    D.3.2Product code N03AX16
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.3Other descriptive namePregabalin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lyrica®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePregabalin
    D.3.2Product code N03AX16
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.3Other descriptive namePregabalin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Painful Diabetic Peripheral Neuropathy
    E.1.1.1Medical condition in easily understood language
    Diabetic Peripheral Neuropathy is a peripheral nerve disorder sometimes caused by diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012683
    E.1.2Term Diabetic peripheral neuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There are two co-primary objectives for this study. In patients with painful DPN, to evaluate the efficacy of pregabalin compared to placebo in:
    1. The reduction in DPN pain; and
    2. The reduction in DPN pain on walking.
    E.2.2Secondary objectives of the trial
    In addition, the study will assess if pregabalin provides other benefits associated with improved functional outcomes (secondary objectives). The safety and tolerability of pregabalin will also be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including the training and completion of the daily pain and sleep diaries using the IVRS system;
    3. Men or women who are at least 18 years of age;
    4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    5. Diagnosis of type 1 or 2 diabetes mellitus with current hemoglobin A1C levels of ≤11%. If the subject is on an antidiabetic medication regimen, it must be stable for the 30 days prior to Visit 2/Randomization;
    6. Diagnosis of painful, diabetic distal symmetrical sensorimotor, polyneuropathy for at least 3 months; (refer to Appendix 1 of the protocol for Diagnostic Worksheet for DPN);
    7. Ability to walk 50 feet (15.2 m) on a flat surface unassisted.
    8. Meet the following 2 criteria demonstrating inadequate pain control:
    • At Visit 1, Screening, a score of ≥4 on the one-week recall, 0-10-point numerical rating scale (Weekly-Pain NRS)
    • At Visit 2/Randomization, subjects must have completed at least 4 daily pain diaries over the past 7 days (baseline) and have an average daily DPN pain score of ≥4 on the 0-10 point numeric rating scale (daily pain diary).
    9. Meet all of the following criteria demonstrating pain on walking after the walk test. The walk test will consist of walking 50 feet (15.2 meters) on a flat surface with one turn allowed, ie, 25 feet in one direction and then return), and then immediate completion of the DPN pain on walking NRS:
    • A post-walk pain score of at least 4 or greater, at both V1/Screening and V2/Randomization.
    • The post-walk pain score (DPN pain on walking NRS) must be greater than the pre-walk pain score at both V1/Screening and V2/Randomization.
    E.4Principal exclusion criteria
    1. Have failed pregabalin treatment due to lack of efficacy at therapeutic doses, have intolerance to pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reasons other than lack of efficacy or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted;
    2. A pain fluctuation of more than a 4 point difference from the highest to the lowest score during the baseline week as assessed by the daily pain diary;
    3. Use of an aid while walking, difficulty with standing upright or inability to walk 50 feet;
    4. Significant peripheral vascular disease (arterial or venous) causing pain on walking. History of intermittent claudication;
    5. Neurological disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain (Refer to Appendix 1of the protocol);
    6. Neurological or other disorders unrelated to diabetic neuropathy that might confound assessments of pain on walking (eg, spinal stenosis, active back pain or sciatica); vascular conditions or local foot conditions (eg, plantar fasciitis) or other conditions (eg, knee pain, arthritis) that could cause pain on walking;
    7. Pain due to other conditions, that in the opinion of the investigator, may confound assessment or self-evaluation of the pain due to diabetic neuropathy;
    8. Clinically significant unstable diabetes mellitus, or unstable hepatic, respiratory, or hematologic illnesses, unstable cardiovascular disease (including a myocardial infarction in the 3 months prior to Visit 1/Screening), or symptomatic peripheral vascular disease;
    9. Any amputation of lower extremities, foot ulcers involving the great toes, or presence of significant pedal edema;
    10. History or current evidence of any condition that could lead to impaired absorption of vitamin B12 (pernicious anemia, chronic gastritis of any cause, surgery such as gastrectomy or gastric bypass surgery, etc.).
    11. A history of untreated hypothyroidism in the past 12 months, or HIV infection;
    12. Have had a malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years;
    13. Have creatinine clearance (CLcr) ≤60 mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation; see Section 7.2.1.of the protocol. Subjects who have an estimated CLcr ≤60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24 hour urine collection performed at the central laboratory. If this 24 hour urine CLcr is >60 mL/min, the subject will be considered eligible for this parameter;
    14. Abnormal (clinically significant) electrocardiogram (ECG);
    15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study;
    16. Currently receiving pregabalin or opioids for painful DPN. Subjects requiring opioid use are excluded. However, subjects may be eligible if opioids are washed out at least 4 weeks prior to V1 and following informed consent, if being discontinued as part of this study;
    17. Use of prohibited concomitant medications which cannot be safely washed out prior to study participation. Prohibited medications are: NSAIDs for DPN pain, opioids, TCAs, SNRIs (eg, duloxetine, venlafaxine), topicals (eg, lidocaine), or benzodiazepines. NSAIDs used acutely (2 times per week or less) to treat conditions other than DPN, are allowed;
    18. Participation in other studies within 30 days before the current study begins and/or during study participation;
    19. Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment as described in Section 7.3.2. of the protocol.
    20. Abuse of illicit drugs or alcohol within the last 2 years;
    21. Positive urine toxic screen for drugs and alcohol. Subjects who are positive for alcohol, illegal drugs, opiates (not prescribed or where washout is not planned), benzodiazepines (unless prescribed and washout is planned), and cannabis are excluded. Subjects positive for cannabis may be re-screened if they do not meet abuse criteria and agree to abstain during the trial; subjects positive on the drug screen where the subject is prescribed a drug in that class (eg, opiate) may washout of the disallowed drug and have the urine toxic screen repeated at Visit 2 to confirm washout.
    22. Unlikely to be able to comply with the protocol because of any reason.
    For a full list of exclusion criteria please see the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:
    • Reduction in DPN pain, as assessed by the endpoint mean pain score based on the mean of the last 7 daily pain numeric rating scale (NRS) scores from the daily pain diaries while receiving study medication in each treatment period (daily pain diary, 0-10 point NRS).
    • Reduction in DPN pain on walking as assessed by the subject’s report of DPN pain on walking, using a 0-10 point NRS, that is completed immediately after walking 50 ft (15.2 m) on a flat surface (DPN pain on walking NRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Reduction in DPN pain, as from the daily pain diaries while receiving study medication in each treatment period
    (V2-V6 & V7-V11)

    Reduction in DPN on walking, completed before and immediately after walking 50ft (15.2m) on a flat surface
    (V1, V2, V5, V6/ET, V10 & V11/ET)
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Responder rate based on a 30% and 50% improvement in mean pain response (from daily pain diary);
    • Brief Pain Inventory-short form (BPI-sf);
    • Actigraph device worn on hip during waking hours (to measure steps and daytime activity);
    • Walk-12;
    • Norfolk Quality of Life Questionnaire for Diabetic Neuropathy (QOL-DN) modified with 2 week recall;
    • Patient Global Impression of Change (PGIC), assessed at the end of period 1 compared to the start of treatment;
    • Sleep Interference Rating Scale (daily sleep diary);
    • Hospital Anxiety and Depression Scale (HADS);
    • Euro QoL-5 Dimensions (EQ-5D).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Responder rate based on a 30% and 50% improvement in mean pain response (from daily pain diary) (V2-V6 & V7-V11);
    • Brief Pain Inventory-short form (BPI-sf) - V2, V6/ET & V11/ET;
    • Actigraph device worn on hip during waking hours (to measure steps and daytime activity) - V2, V6/ET & V11/ET
    • Walk-12 (V2, V6/ET & V11/ET);
    • Norfolk Quality of Life Questionnaire for Diabetic Neuropathy (QOL-DN) modified with 2 week recall (V2, V6/ET & V11/ET);
    • Patient Global Impression of Change (PGIC), assessed at the end of period 1 compared to the start of treatment (V6/ET & V11/ET);
    • Sleep Interference Rating Scale (daily sleep diary) V1-V12:
    • Hospital Anxiety and Depression Scale (HADS) V2, V6/ET & V11/ET
    • Euro QoL-5 Dimensions (EQ-5D) V2, V6/ET & V11/ET .
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    South Africa
    Sweden
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As per the protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-02
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