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Chronic DiseasePhase 4ConvERTNCT01179191

Conversion to Embeda With Rescue Trial

A Phase 4 study testing morphine sulfate and naltrexone hydrochloride (EMBEDA) in people with Chronic Disease and Pain, run by Pfizer at 166 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chronic Disease, Pain
What is being tested?
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
684 participants
Where
166 sitesUnited States
Study dates
Aug 2010to Apr 2011
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

166 sites in 1 country.

166 sites in 1 country

United States166 sites

  • Adamsville Family Medicine

    Adamsville, Alabama, 35005

  • Pennsylvania Pain Specialists, PC

    Allentown, Pennsylvania, 18102

  • The Reiter Foundation, Inc.

    Anaconda, Montana, 59711

  • Hartwell Research Group, LLC

    Anderson, South Carolina, 29621

  • Carolina Clinical Research and Consulting, LLC

    Asheboro, North Carolina, 27203

  • Carolina Clinical Research and Consulting, LLC

    Asheboro, North Carolina, 27205

  • Ware Medical Associates, PC

    Aston Mills, Pennsylvania, 19014

  • Atco Medical Associates, PC

    Atco, New Jersey, 08004

  • Perimeter Institute for Clinical Research, Inc.

    Atlanta, Georgia, 30338

  • Rocky Mountain Internal Medicine, PC

    Aurora, Colorado, 80012

  • Office of John V. Bernard, MD

    Belvidere, New Jersey, 07823

  • Anesthesia and Pain Control Services

    Biloxi, Mississippi, 39531

  • Office of David McLain

    Birmingham, Alabama, 35209

  • Progressive Clinical Research, LLC

    Bountiful, Utah, 84010

  • Orthopedic Research Institute, LLC

    Boynton Beach, Florida, 33472

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Medical Frontiers, LLC

    Carlisle, Ohio, 45005

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Low Country Rheumatology, PA

    Charleston, South Carolina, 29406

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina, 29412

  • Joint and Muscle Research Institute, Inc.

    Charlotte, North Carolina, 28204

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Chicago Clinical Research Institute Inc.

    Chicago, Illinois, 60616

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45236

  • Clarkston Medical Group, PC

    Clarkston, Michigan, 48346

  • Florida Research & Testing, LLC

    Clearwater, Florida, 33755

  • Diseasebusters, LLC

    College Park, Maryland, 20740

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

  • Medical Research and Health Education Foundation, Inc.

    Columbus, Georgia, 31909

  • Corsicana Medical Research, PLLC

    Corsicana, Texas, 75110

  • CSI Clinical Trials

    Costa Mesa, California, 92626

  • Creve Coeur Family Practice

    Creve Coeur, Illinois, 61610

  • DCT - Genesis Neighborhood Research, LLC

    Dallas, Texas, 75254

  • Omega Research Consultants, LLC

    DeBary, Florida, 32713

  • Omega Research Consultants, LLC

    DeBary, Florida, 32746

  • Ialum Clinical Research, LLC

    Decatur, Georgia, 30032

  • Delaware Smith Clinic Research

    Delaware, Ohio, 43015

  • Altoona Center for Clinical Research, PC

    Duncansville, Pennsylvania, 16635

  • West Florida Medical Associate, PA

    Dunnellon, Florida, 34432

  • MAPS Applied Research Center, Inc.

    Edina, Minnesota, 55435

  • Washington Center for Pain Management PLLC

    Edmonds, Washington, 98026

  • Southwest Urgent Care Center

    El Paso, Texas, 79902

  • Central Jersey Medical Research Center, Inc.

    Elizabeth, New Jersey, 07202

  • Ronald J. Rapoport, MD, PC

    Fall River, Massachusetts, 02720

  • Apex Medical Research, AMR, Inc.

    Flint, Michigan, 48504

  • East Michigan Medical Associates

    Flint, Michigan, 48507

  • Patterson Medical Clinic, Inc.

    Florissant, Missouri, 63031

  • Quality Clinical Research Inc.

    Florissant, Missouri, 63033

  • Global Wellness Medical Corporation

    Foothill Ranch, California, 92610

  • Saint Luke's Medical Clinic, LLC

    Fort Collins, Colorado, 80525

  • Medical Frontiers, LLC

    Franklin, Ohio, 45005

  • Adirondack Medical Research Center

    Glens Falls, New York, 12801

  • Dedicated Clinical Research

    Goodyear, Arizona, 85395

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • Internal Medicine of Greer Research LLC

    Greer, South Carolina, 29650

  • Center for Pain Management

    Hackensack, New Jersey, 07601

  • Advocare Heights Primary Care

    Haddon Heights, New Jersey, 08035

  • Kandra, Fierer, Kuskin Associates, Ltd.

    Harrisburg, Pennsylvania, 17112

  • Drug Trials America, Inc.

    Hartsdale, New York, 10530

  • Comprehensive Pain Specialists

    Hendersonville, Tennessee, 37075

  • International Research Associates, LLC

    Hialeah, Florida, 33012

  • Palm Springs Research Institute, Inc

    Hialeah, Florida, 33012

  • Catawba Valley Internal Medicine

    Hickory, North Carolina, 28602

  • Ouachita Regional Pain Management

    Hot Springs, Arkansas, 71913

  • Westbury Medical Clinic

    Houston, Texas, 77005

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77034

  • Medstar Clinical Research

    Houston, Texas, 77083

  • Pain Care, PLLC

    Huntington, West Virginia, 25701

  • Monte Sano Clinical Research, LLC

    Huntsville, Alabama, 35801

  • Tennessee Valley Pain Consultants Properties, LLC

    Huntsville, Alabama, 35801

  • Josephson Wallack Munshower Neurology P.C.

    Indianapolis, Indiana, 46237

  • Chrishard Medical Group

    Inglewood, California, 90301

  • CRC of Jackson, LLC

    Jackson, Mississippi, 39202

  • Profen Research Network at ECMA

    Jacksonville, North Carolina, 28546

  • Primary Care Medicine, PC

    Jefferson City, Missouri, 65109

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • FPA Clinical Research, LLC

    Kissimmee, Florida, 34741

  • Triwest Research Associates LLC

    La Mesa, California, 91942

  • Pacific Coast Pain Management Center

    Laguna Hills, California, 92637

  • Portland Rheumatology Clinic, LLC

    Lake Oswego, Oregon, 97035

  • Clinical Research of Central Florida, Inc.

    Lakeland, Florida, 33810

  • PCM Medical Services, PC

    Lansing, Michigan, 48910

  • The Pain Treatment Center of the Bluegrass

    Lexington, Kentucky, 40503

  • NJ Heart, LLC

    Linden, New Jersey, 07036

  • Valerius Medical Group and Research Center of Greater Long Beach, Inc.

    Long Beach, California, 90806

  • Office of Roger Kasendorf, DO

    Long Beach, New York, 11561

  • LA Pain & Wellness Institute

    Los Angeles, California, 90017

  • Samaritan Center for Medical Research

    Los Gatos, California, 95032

  • Healing Options

    Louisville, Kentucky, 40223

  • ProHealth Physicians PC

    Manchester, Connecticut, 06040

  • Family Health Medical Services PLLC

    Mayville, New York, 14757

  • Community Research Foundation, Inc.

    Miami, Florida, 33155

  • New Horizon Research Center, Inc.

    Miami, Florida, 33175

  • NextPhase Clinical Trials, Inc.

    Miami Beach, Florida, 33140

  • Laporte County Institute for Clinical Research Inc.

    Michigan City, Indiana, 46360

  • Milford Physician Services, PC

    Milford, Connecticut, 06460

  • Office of Joseph E. Yankee, DO, PC

    Milwaukie, Oregon, 97222

  • McKinley Research, LLC

    Mishawaka, Indiana, 46545

  • Sunbelt Research Group, LLC

    Mobile, Alabama, 36693

  • Office of Vaughn H. Mancha, Jr., PC

    Montgomery, Alabama, 36117

  • Clinical Research Authority, LLC

    Murrells Inlet, South Carolina, 29576

  • Jeffrey J. Haggenjos, DO, Inc.

    New Lexington, Ohio, 43764

  • Newport Beach Clinical Research Associates, Inc.

    Newport Beach, California, 92663

  • Sentara Medical Group, NDC Medical Center

    Norfolk, Virginia, 23502

  • Trident Institute of Medical Research, LLC

    North Charleston, South Carolina, 29406

  • Harmony Clinical Research, Inc.

    North Miami Beach, Florida, 33162

  • Office of Laszlo J. Mate, MD, PA

    North Palm Beach, Florida, 33408

  • New York Spine & Wellness Center

    North Syracuse, New York, 13212

  • Office of Richard E. Promin, MD, PA

    Ocala, Florida, 34474

  • Health Research Institute, LLC

    Oklahoma City, Oklahoma, 73109

  • Office of Siavash Nael, MD, Inc.

    Oklahoma City, Oklahoma, 73109

  • Medical Pain Relief Clinic

    Omaha, Nebraska, 68114

  • Omaha Clinical Research, PC

    Omaha, Nebraska, 68116

  • Low Country Pain Center, LLC

    Orangeburg, South Carolina, 29118

  • Four Rivers Clinical Research, Inc.

    Paducah, Kentucky, 42003

  • Hollis Family Medical Clinic, PLC

    Paragould, Arkansas, 72450

  • Bayview Research Group, LLC

    Paramount, California, 90723

  • Pasadena Rehabilitation Institute

    Pasadena, California, 91105

  • Office of Rebecca Knight, MD

    Peoria, Illinois, 61614

  • Whole Family Medical Care LLC

    Perrysburg, Ohio, 43551

  • Onuorah Umeh, M.D. P.C

    Philadelphia, Pennsylvania, 19104

  • Founders Research Corporation

    Philadelphia, Pennsylvania, 19152

  • Dedicated Clinical Research, Inc

    Phoenix, Arizona, 85020

  • Redpoint Research

    Phoenix, Arizona, 85029

  • Anasazi Internal Medicine, PC

    Phoenix, Arizona, 85032

  • Office of Steven C. Miller, MD

    Pikesville, Maryland, 21208

  • Advent Clinical Research Centers, Inc.

    Pinellas Park, Florida, 33781

  • Pain Management Strategies, Inc.

    Pompano Beach, Florida, 33064

  • Remedica LLC

    Rochester, Michigan, 48307

  • Quality Control Research, Inc.

    Roseville, California, 95661

  • Lakewood Family Practice

    Russell Springs, Kentucky, 42642

  • Northern California Research

    Sacramento, California, 95821

  • Quality Control Research, Inc.

    Sacramento, California, 95842

  • Office of Jocelyn F. Shimek, DO

    Salem, Ohio, 44460

  • Texas Medical Research Associates, LLC

    San Antonio, Texas, 78238

  • Rancho Santa Fe Medical Group, Inc.

    San Marcos, California, 92078

  • Probe Clinical Research Corporation

    Santa Ana, California, 92701

  • Trinity Clinical Trials

    Santa Ana, California, 92701

  • Sarasota Pain Medicine Research, LLC

    Sarasota, Florida, 34238

  • MAPS Applied Research Center, Inc.

    Shakopee, Minnesota, 55379

  • Spine and Pain Centers, PA

    Shrewsbury, New Jersey, 07702

  • Cochise Clinical Research

    Sierra Vista, Arizona, 85635

  • Accelovance, Inc.

    South Bend, Indiana, 46601

  • Midsouth Anesthesia Consultants, PLLC

    Southhaven, Mississippi, 38671

  • Michigan Lifestyle Change and Health Center, PC

    Sterling, Michigan, 48314

  • Associates of Medicine/John D. Williams, MD, PLLC

    Stillwater, Oklahoma, 74074

  • Ialum Clinical Research, LLC

    Stone Mountain, Georgia, 30088

  • Herman Clinical Research, LLC

    Suwanee, Georgia, 30024

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Premiere Phamaceutical Research, LLC

    Tempe, Arizona, 85282

  • Office of James Lassiter

    Tiffin, Ohio, 44883

  • Centers for Pain Management

    Tifton, Georgia, 31794

  • Premier Research, Inc.

    Trenton, New Jersey, 08611

  • Quality of Life Medical and Research Center, LLC

    Tucson, Arizona, 85712

  • Facility Medical Center

    Upland, California, 91786

  • North American Partners in Pain Management, LLP

    Valley Stream, New York, 11580

  • Bayview Research Group, LLC

    Valley Village, California, 91607

  • Hillcrest Family Health Center, Division of Clinical Research

    Waco, Texas, 76710

  • Hillcrest Family Health Center

    Waco, Texas, 76710

  • Boston Paincare Center, Inc.

    Waltham, Massachusetts, 02154

  • Brown Clinic, PLLP

    Watertown, South Dakota, 57201

  • Clinical Research Center, LLC

    Wellington, Florida, 33414

  • Des Moines Orthopaedic Surgeons, PC

    West Des Moines, Iowa, 50266

  • Progressive Pain Solutions, LLC

    Wind Gap, Pennsylvania, 18091

  • The Center For Clinical Research, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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 Diversion

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.

Read the detailed description

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.

Being tested
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Keywords
chronic pain, Embeda, opioid, moderate pain, severe pain, conversion, converting, switching, morphine, aberrant behavior, Pain (DT) + Chronic Disease (DT)
Medical subject headings
Chronic Disease, Pain, Chronic Pain

What participants receive

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

  • morphine sulfate and naltrexone hydrochloride (EMBEDA)Drug

    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.

Study groups in NCT01179191
Study groupRoleWhat they receive
morphine sulfate and naltrexone hydrochloride (EMBEDA)ExperimentalNot described
Receives: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)

What is being measured

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

  1. Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase

    A 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.

    Measured: Baseline through Week 6

  2. Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy

    A 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.

    Measured: Baseline through Week 6

Secondary outcomes (7)

  1. Duration to Titrate Participants to Stable Dose

    A 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.

    Measured: Baseline through Week 6

  2. Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy

    A 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.

    Measured: Baseline through Week 6

  3. Number of Titration Steps to Achieve Stable Dose

    A 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.

    Measured: Baseline through Week 6

  4. Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy

    A 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.

    Measured: Baseline through Week 6

  5. Percentage of Participants With Rescue Medications Usage During Titration

    Rescue 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.

    Measured: Baseline through Week 6

  6. Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)

    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.

    Measured: Baseline, Visit 3 (up to Week 6)

  7. Investigator's Level of Satisfaction With the EMBEDA Conversion Guide

    The 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.

    Measured: Week 6

Timeline

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

  1. First posted11 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionApr 2011
  4. Study completionApr 2011

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
684 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01179191
Sponsor's protocol ID
ALO-01-10-4003
Other IDs
B4541001
Acronym
ConvERT
Status last verified
Oct 2012
First submitted
30 Jul 2010
Last updated
11 Oct 2012
Data monitoring committee
No

Publications

  • Setnik B, Roland CL, Pixton GC, Sommerville KW. Prescription opioid abuse and misuse: gap between primary-care investigator assessment and actual extent of these behaviors among patients with chronic pain. Postgrad Med. 2017 Jan;129(1):5-11. doi: 10.1080/00325481.2017.1245585. Epub 2016 Oct 26.

    PubMed 27782769

  • Setnik B, Roland CL, Sommerville KW, Pixton GC, Berke R, Calkins A, Goli V. A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide. J Pain Res. 2015 Jul 8;8:347-60. doi: 10.2147/JPR.S82395. eCollection 2015.

    PubMed 26185466

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing morphine sulfate and naltrexone hydrochloride (EMBEDA) in people with Chronic Disease and Pain, run by Pfizer at 166 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 13 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Sep 2012). 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?

Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase (time frame: Baseline through Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01179191, 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 11 Oct 2012.

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Conversion to Embeda With Rescue Trial (NCT01179191) | AzTrials