ClinicalTrials.gov processed this data on March 27, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT01179191ALO-01-10-4003B4541001NCT01179191Conversion to Embeda With Rescue Trial
ConvERT
A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and DiversionPfizerIndustryNo
The purpose of the research study is to find out if opioid dependent chronic pain patients
who are judged by their physician to be eligible to change their current opioid medicine and
to participate in this study can be successfully adjusted to a stable dose of EMBEDA
(morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's
risk for prescription opioid abuse, misuse and diversion.
The decision to terminate the trial was based on a lack of study drug supply. The decision
was not based on any safety concerns. The termination letter was sent on 11March2011.
Terminated
See termination reason in detailed description.
August 2010April 2011April 2011Phase 4InterventionalNoN/ASingle Group AssignmentSupportive CareNone (Open Label)Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration PhaseBaseline through Week 6A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid TherapyBaseline through Week 6A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.Duration to Titrate Participants to Stable DoseBaseline through Week 6A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid TherapyBaseline through Week 6A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.Number of Titration Steps to Achieve Stable DoseBaseline through Week 6A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid TherapyBaseline through Week 6A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.Percentage of Participants With Rescue Medications Usage During TitrationBaseline through Week 6Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)Baseline, Visit 3 (up to Week 6)BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.Investigator's Level of Satisfaction With the EMBEDA Conversion GuideWeek 6The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.Number of Participants With Aberrant BehaviorsDay 5Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = 'never' and 4 = 'very often']. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.Number of Participants With Abnormal Urine Drug Test ResultsBaseline, Visit 3 (up to Week 6)Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.Number of Participants With Urine Drug Test Results Positive for Unaccounted OpioidsVisit 3 (up to Week 6)Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.Number of Participants With Urine Drug Test Results Positive for Illicit SubstancesBaseline, Visit 3 (up to Week 6)Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected OpioidBaseline, Visit 3 (up to Week 6)Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.1684Chronic DiseasePainmorphine sulfate and naltrexone hydrochloride (EMBEDA)ExperimentalDrugmorphine sulfate and naltrexone hydrochloride (EMBEDA)Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.morphine sulfate and naltrexone hydrochloride (EMBEDA)
Inclusion Criteria:
- Be able to read, speak and understand English
- Have chronic moderate to severe pain for at least 3 months
- Require around the clock opioid medication for the relief of pain
- Have been taking a daily opioid for at least 30 days prior to starting the study
- Be able to be safely switched to a different pain medication
- Be practicing acceptable birth control methods for female patients of childbearing
potential
- Be willing to participate in the study and able to comply with study procedures
Exclusion Criteria:
- Be currently diagnosed with or participating in and/or seeking treatment for opioid
and/or alcohol abuse
- Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
- Be currently taking tramadol and/or extended release morphine products
- Have respiratory depression
- Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
- Have migraines as your main source of pain
- Have any form of bowel obstruction
- Be pregnant or breast feeding
- Have had 2 or more surgeries for low back pain
- Be planning a major surgery during the study
- Be staying in a hospital or nursing home
- Be planning to have steroid injections for your chronic pain during the study
- Have a life expectancy of less than 2 months
All21 YearsN/ANoPfizer CT.gov Call CenterStudy DirectorPfizerAdamsville Family MedicineAdamsvilleAlabama35005United StatesOffice of David McLainBirminghamAlabama35209United StatesMonte Sano Clinical Research, LLCHuntsvilleAlabama35801United StatesTennessee Valley Pain Consultants Properties, LLCHuntsvilleAlabama35801United StatesSunbelt Research Group, LLCMobileAlabama36693United StatesOffice of Vaughn H. Mancha, Jr., PCMontgomeryAlabama36117United StatesDedicated Clinical ResearchGoodyearArizona85395United StatesDedicated Clinical Research, IncPhoenixArizona85020United StatesRedpoint ResearchPhoenixArizona85029United StatesAnasazi Internal Medicine, PCPhoenixArizona85032United StatesCochise Clinical ResearchSierra VistaArizona85635United StatesPremiere Phamaceutical Research, LLCTempeArizona85282United StatesQuality of Life Medical and Research Center, LLCTucsonArizona85712United StatesOuachita Regional Pain ManagementHot SpringsArkansas71913United StatesNEA Baptist ClinicJonesboroArkansas72401United StatesHollis Family Medical Clinic, PLCParagouldArkansas72450United StatesCSI Clinical TrialsCosta MesaCalifornia92626United StatesGlobal Wellness Medical CorporationFoothill RanchCalifornia92610United StatesChrishard Medical GroupInglewoodCalifornia90301United StatesTriwest Research Associates LLCLa MesaCalifornia91942United StatesPacific Coast Pain Management CenterLaguna HillsCalifornia92637United StatesValerius Medical Group and Research Center of Greater Long Beach, Inc.Long BeachCalifornia90806United StatesLA Pain & Wellness InstituteLos AngelesCalifornia90017United StatesSamaritan Center for Medical ResearchLos GatosCalifornia95032United StatesNewport Beach Clinical Research Associates, Inc.Newport BeachCalifornia92663United StatesBayview Research Group, LLCParamountCalifornia90723United StatesPasadena Rehabilitation InstitutePasadenaCalifornia91105United StatesQuality Control Research, Inc.RosevilleCalifornia95661United StatesNorthern California ResearchSacramentoCalifornia95821United StatesQuality Control Research, Inc.SacramentoCalifornia95842United StatesRancho Santa Fe Medical Group, Inc.San MarcosCalifornia92078United StatesProbe Clinical Research CorporationSanta AnaCalifornia92701United StatesTrinity Clinical TrialsSanta AnaCalifornia92701United StatesFacility Medical CenterUplandCalifornia91786United StatesBayview Research Group, LLCValley VillageCalifornia91607United StatesRocky Mountain Internal Medicine, PCAuroraColorado80012United StatesClinicos, LLCColorado SpringsColorado80904United StatesSaint Luke's Medical Clinic, LLCFort CollinsColorado80525United StatesProHealth Physicians PCManchesterConnecticut06040United StatesMilford Physician Services, PCMilfordConnecticut06460United StatesOrthopedic Research Institute, LLCBoynton BeachFlorida33472United StatesFlorida Research & Testing, LLCClearwaterFlorida33755United StatesOmega Research Consultants, LLCDebaryFlorida32713United StatesOmega Research Consultants, LLCDeBaryFlorida32746United StatesWest Florida Medical Associate, PADunnellonFlorida34432United StatesInternational Research Associates, LLCHialeahFlorida33012United StatesPalm Springs Research Institute, IncHialeahFlorida33012United StatesFPA Clinical Research, LLCKissimmeeFlorida34741United StatesClinical Research of Central Florida, Inc.LakelandFlorida33810United StatesNextPhase Clinical Trials, Inc.Miami BeachFlorida33140United StatesCommunity Research Foundation, Inc.MiamiFlorida33155United StatesNew Horizon Research Center, Inc.MiamiFlorida33175United StatesHarmony Clinical Research, Inc.North Miami BeachFlorida33162United StatesOffice of Laszlo J. Mate, MD, PANorth Palm BeachFlorida33408United StatesOffice of Richard E. Promin, MD, PAOcalaFlorida34474United StatesAdvent Clinical Research Centers, Inc.Pinellas ParkFlorida33781United StatesPain Management Strategies, Inc.Pompano BeachFlorida33064United StatesSarasota Pain Medicine Research, LLCSarasotaFlorida34238United StatesStedman Clinical Trials, LLCTampaFlorida33613United StatesClinical Research Center, LLCWellingtonFlorida33414United StatesPerimeter Institute for Clinical Research, Inc.AtlantaGeorgia30338United StatesMedical Research and Health Education Foundation, Inc.ColumbusGeorgia31909United StatesIalum Clinical Research, LLCDecaturGeorgia30032United StatesIalum Clinical Research, LLCStone MountainGeorgia30088United StatesHerman Clinical Research, LLCSuwaneeGeorgia30024United StatesCenters for Pain ManagementTiftonGeorgia31794United StatesChicago Clinical Research Institute Inc.ChicagoIllinois60616United StatesCreve Coeur Family PracticeCreve CoeurIllinois61610United StatesOffice of Rebecca Knight, MDPeoriaIllinois61614United StatesJosephson Wallack Munshower Neurology P.C.IndianapolisIndiana46237United StatesLaporte County Institute for Clinical Research Inc.Michigan CityIndiana46360United StatesMcKinley Research, LLCMishawakaIndiana46545United StatesAccelovance, Inc.South BendIndiana46601United StatesDes Moines Orthopaedic Surgeons, PCWest Des MoinesIowa50266United StatesThe Pain Treatment Center of the BluegrassLexingtonKentucky40503United StatesHealing OptionsLouisvilleKentucky40223United StatesFour Rivers Clinical Research, Inc.PaducahKentucky42003United StatesLakewood Family PracticeRussell SpringsKentucky42642United StatesDiseasebusters, LLCCollege ParkMaryland20740United StatesOffice of Steven C. Miller, MDPikesvilleMaryland21208United StatesBeacon Clinical Research, LLCBrocktonMassachusetts02301United StatesRonald J. Rapoport, MD, PCFall RiverMassachusetts02720United StatesBoston Paincare Center, Inc.WalthamMassachusetts02154United StatesClarkston Medical Group, PCClarkstonMichigan48346United StatesApex Medical Research, AMR, Inc.FlintMichigan48504United StatesEast Michigan Medical AssociatesFlintMichigan48507United StatesPCM Medical Services, PCLansingMichigan48910United StatesRemedica LLCRochesterMichigan48307United StatesMichigan Lifestyle Change and Health Center, PCSterlingMichigan48314United StatesMAPS Applied Research Center, Inc.EdinaMinnesota55435United StatesMAPS Applied Research Center, Inc.ShakopeeMinnesota55379United StatesAnesthesia and Pain Control ServicesBiloxiMississippi39531United StatesCRC of Jackson, LLCJacksonMississippi39202United StatesMidsouth Anesthesia Consultants, PLLCSouthhavenMississippi38671United StatesPatterson Medical Clinic, Inc.FlorissantMissouri63031United StatesQuality Clinical Research Inc.FlorissantMissouri63033United StatesPrimary Care Medicine, PCJefferson CityMissouri65109United StatesThe Reiter Foundation, Inc.AnacondaMontana59711United StatesMedical Pain Relief ClinicOmahaNebraska68114United StatesOmaha Clinical Research, PCOmahaNebraska68116United StatesAtco Medical Associates, PCAtcoNew Jersey08004United StatesOffice of John V. Bernard, MDBelvidereNew Jersey07823United StatesCentral Jersey Medical Research Center, Inc.ElizabethNew Jersey07202United StatesCenter for Pain ManagementHackensackNew Jersey07601United StatesAdvocare Heights Primary CareHaddon HeightsNew Jersey08035United StatesNJ Heart, LLCLindenNew Jersey07036United StatesSpine and Pain Centers, PAShrewsburyNew Jersey07702United StatesPremier Research, Inc.TrentonNew Jersey08611United StatesAdirondack Medical Research CenterGlens FallsNew York12801United StatesLong Island Gastrointestinal Research Group LLPGreat NeckNew York11023United StatesDrug Trials America, Inc.HartsdaleNew York10530United StatesOffice of Roger Kasendorf, DOLong BeachNew York11561United StatesFamily Health Medical Services PLLCMayvilleNew York14757United StatesNew York Spine & Wellness CenterNorth SyracuseNew York13212United StatesNorth American Partners in Pain Management, LLPValley StreamNew York11580United StatesCarolina Clinical Research and Consulting, LLCAsheboroNorth Carolina27203United StatesCarolina Clinical Research and Consulting, LLCAsheboroNorth Carolina27205United StatesJoint and Muscle Research Institute, Inc.CharlotteNorth Carolina28204United StatesCatawba Valley Internal MedicineHickoryNorth Carolina28602United StatesProfen Research Network at ECMAJacksonvilleNorth Carolina28546United StatesThe Center For Clinical Research, LLCWinston-SalemNorth Carolina27103United StatesMedical Frontiers, LLCCarlisleOhio45005United StatesValley Medical ResearchCentervilleOhio45459United StatesHightop Medical Research CenterCincinnatiOhio45224United StatesSentral Clinical Research ServicesCincinnatiOhio45236United StatesDelaware Smith Clinic ResearchDelawareOhio43015United StatesMedical Frontiers, LLCFranklinOhio45005United StatesJeffrey J. Haggenjos, DO, Inc.New LexingtonOhio43764United StatesWhole Family Medical Care LLCPerrysburgOhio43551United StatesOffice of Jocelyn F. Shimek, DOSalemOhio44460United StatesOffice of James LassiterTiffinOhio44883United StatesHealth Research Institute, LLCOklahoma CityOklahoma73109United StatesOffice of Siavash Nael, MD, Inc.Oklahoma CityOklahoma73109United StatesAssociates of Medicine/John D. Williams, MD, PLLCStillwaterOklahoma74074United StatesPortland Rheumatology Clinic, LLCLake OswegoOregon97035United StatesOffice of Joseph E. Yankee, DO, PCMilwaukieOregon97222United StatesPennsylvania Pain Specialists, PCAllentownPennsylvania18102United StatesWare Medical Associates, PCAstonPennsylvania19014United StatesAltoona Center for Clinical Research, PCDuncansvillePennsylvania16635United StatesKandra, Fierer, Kuskin Associates, Ltd.HarrisburgPennsylvania17112United StatesOnuorah Umeh, M.D. P.CPhiladelphiaPennsylvania19104United StatesFounders Research CorporationPhiladelphiaPennsylvania19152United StatesProgressive Pain Solutions, LLCWind GapPennsylvania18091United StatesHartwell Research Group, LLCAndersonSouth Carolina29621United StatesLow Country Rheumatology, PACharlestonSouth Carolina29406United StatesPharmacorp Clinical Trials, Inc.CharlestonSouth Carolina29412United StatesInternal Medicine of Greer Research LLCGreerSouth Carolina29650United StatesClinical Research Authority, LLCMurrells InletSouth Carolina29576United StatesTrident Institute of Medical Research, LLCNorth CharlestonSouth Carolina29406United StatesLow Country Pain Center, LLCOrangeburgSouth Carolina29118United StatesBrown Clinic, PLLPWatertownSouth Dakota57201United StatesChattanooga Medical Research, LLCChattanoogaTennessee37404United StatesComprehensive Pain SpecialistsHendersonvilleTennessee37075United StatesCorsicana Medical Research, PLLCCorsicanaTexas75110United StatesDCT - Genesis Neighborhood Research, LLCDallasTexas75254United StatesSouthwest Urgent Care CenterEl PasoTexas79902United StatesWestbury Medical ClinicHoustonTexas77005United StatesAccurate Clinical Research, Inc.HoustonTexas77034United StatesMedstar Clinical ResearchHoustonTexas77083United StatesTexas Medical Research Associates, LLCSan AntonioTexas78238United StatesHillcrest Family Health Center, Division of Clinical ResearchWacoTexas76710United StatesHillcrest Family Health CenterWacoTexas76710United StatesProgressive Clinical Research, LLCBountifulUtah84010United StatesSentara Medical Group, NDC Medical CenterNorfolkVirginia23502United StatesWashington Center for Pain Management PLLCEdmondsWashington98026United StatesPain Care, PLLCHuntingtonWest Virginia25701United StatesUnited Stateshttps://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-10-4003&StudyName=Conversion%20to%20Embeda%20With%20Rescue%20TrialTo obtain contact information for a study center near you, click here.October 2012July 30, 2010August 10, 2010August 11, 2010July 30, 2012July 30, 2012September 5, 2012April 5, 2012April 5, 2012April 9, 2012October 9, 2012October 9, 2012October 11, 2012Sponsorchronic painEmbedaopioidmoderate painsevere painconversionconvertingswitchingmorphineaberrant behaviorPain (DT) + Chronic Disease (DT)Chronic DiseaseNaltrexoneMorphine