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Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Sponsor
Cubist Pharmaceuticals LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00259922
Collaborator
GlaxoSmithKline (Industry)
485
Enrollment
187
Locations
3
Arms
2.6
Patients Per Site

Study Details

Study Description

Brief Summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
485 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Study Start Date :
Aug 1, 2005
Actual Primary Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
Placebo
Experimental: Alvimopan 0.5 mg once daily

0.5 mg once daily (QD)

Drug: Alvimopan
0.5 mg QD
Other Names:
  • Entereg

    		•
    Experimental: Alvimopan 0.5 mg twice daily

    0.5 mg twice daily (BID)

    Drug: Alviompan
    0.5 mg BID
    Other Names:
  • Entereg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To compare alvimopan with placebo for efficacy in the treatment of OBD []

    Secondary Outcome Measures

    1. Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data) []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Consented to participate in this study.

    • Taking opioid therapy for persistent non-cancer pain.

    • Has bowel dysfunction mainly due to opioids.

    • Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.

    • Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).

    • Willing to report daily bowel symptoms.

    Exclusion criteria:

    • Pregnant, lactating, or planning to become pregnant.

    • Not ambulatory.

    • Participated in another trial with an investigational drug in the past 30 days.

    • Taking opioids for the management of drug addiction or cancer-related pain.

    • Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.

    • Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.

    • HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Birmingham Alabama United States 35215
    2 GSK Investigational Site Birmingham Alabama United States 35216
    3 GSK Investigational Site Huntsville Alabama United States 35801
    4 GSK Investigational Site Mobile Alabama United States 36606
    5 GSK Investigational Site Northport Alabama United States 35476
    6 GSK Investigational Site Mesa Arizona United States 85205
    7 GSK Investigational Site Phoenix Arizona United States 85029
    8 GSK Investigational Site Scottsdale Arizona United States 85251
    9 GSK Investigational Site Scottsdale Arizona United States 85258
    10 GSK Investigational Site Tempe Arizona United States 85282
    11 GSK Investigational Site Tucson Arizona United States 85712
    12 GSK Investigational Site Tucson Arizona United States 85724
    13 GSK Investigational Site Bakersfield California United States 93311
    14 GSK Investigational Site Beverly Hills California United States 90211
    15 GSK Investigational Site Long Beach California United States 90813
    16 GSK Investigational Site Los Angeles California United States 90048
    17 GSK Investigational Site Los Gatos California United States 95032
    18 GSK Investigational Site Northridge California United States 91325
    19 GSK Investigational Site Orange California United States 92868
    20 GSK Investigational Site Palm Springs California United States 92262
    21 GSK Investigational Site Pasadena California United States 91105
    22 GSK Investigational Site Sacramento California United States 95816
    23 GSK Investigational Site San Diego California United States 92108
    24 GSK Investigational Site San Rafael California United States 94901
    25 GSK Investigational Site Santa Ana California United States 92704
    26 GSK Investigational Site Stamford Connecticut United States 06905
    27 GSK Investigational Site Waterbury Connecticut United States 06708
    28 GSK Investigational Site Washington District of Columbia United States 20003
    29 GSK Investigational Site Chiefland Florida United States 32626
    30 GSK Investigational Site Clearwater Florida United States 33761
    31 GSK Investigational Site Deerfield Beach Florida United States 33441
    32 GSK Investigational Site Destin Florida United States 32541
    33 GSK Investigational Site Fort Myers Florida United States 33916
    34 GSK Investigational Site Hollywood Florida United States 33021
    35 GSK Investigational Site Hollywood Florida United States 33023
    36 GSK Investigational Site Largo Florida United States 33770
    37 GSK Investigational Site Margate Florida United States 33063
    38 GSK Investigational Site Miami Florida United States 33138
    39 GSK Investigational Site Miami Florida United States 33155
    40 GSK Investigational Site Miami Florida United States 33169
    41 GSK Investigational Site Ocala Florida United States 34471
    42 GSK Investigational Site Ormond Beach Florida United States 32174
    43 GSK Investigational Site St. Cloud Florida United States 34769
    44 GSK Investigational Site Tampa Florida United States 33614
    45 GSK Investigational Site West Palm Beach Florida United States 33401
    46 GSK Investigational Site Winterhaven Florida United States 33880
    47 GSK Investigational Site Atlanta Georgia United States 30338
    48 GSK Investigational Site Atlanta Georgia United States 30342
    49 GSK Investigational Site Cumming Georgia United States 30040
    50 GSK Investigational Site Marietta Georgia United States 30066
    51 GSK Investigational Site Stockbridge Georgia United States 30281
    52 GSK Investigational Site Meridian Idaho United States 83642
    53 GSK Investigational Site Chicago Illinois United States 60610
    54 GSK Investigational Site Libertyville Illinois United States 60048
    55 GSK Investigational Site Oak Forest Illinois United States 60452
    56 GSK Investigational Site Oakbrook Terrace Illinois United States 60181
    57 GSK Investigational Site Evansville Indiana United States 47714
    58 GSK Investigational Site Indianapolis Indiana United States 46250
    59 GSK Investigational Site Lexington Kentucky United States 40536
    60 GSK Investigational Site Louisville Kentucky United States 40205
    61 GSK Investigational Site Sunset Louisiana United States 70584
    62 GSK Investigational Site Pasadena Maryland United States 21122
    63 GSK Investigational Site Rockville Maryland United States 20852
    64 GSK Investigational Site Boston Massachusetts United States 02115
    65 GSK Investigational Site Brockton Massachusetts United States 02301
    66 GSK Investigational Site Wellesley Hills Massachusetts United States 02481
    67 GSK Investigational Site Portage Michigan United States 49024
    68 GSK Investigational Site Waterford Michigan United States 48327
    69 GSK Investigational Site Olive Branch Mississippi United States 38654
    70 GSK Investigational Site Independence Missouri United States 64055
    71 GSK Investigational Site St. Louis Missouri United States 63108
    72 GSK Investigational Site St. Louis Missouri United States 63141
    73 GSK Investigational Site Missoula Montana United States 59804
    74 GSK Investigational Site Las Vegas Nevada United States 89102
    75 GSK Investigational Site Las Vegas Nevada United States 89103
    76 GSK Investigational Site Las Vegas Nevada United States 89119
    77 GSK Investigational Site Las Vegas Nevada United States 89146
    78 GSK Investigational Site Dover New Hampshire United States 03820
    79 GSK Investigational Site Blackwood New Jersey United States 08012
    80 GSK Investigational Site Egg Harbor Township New Jersey United States 08234
    81 GSK Investigational Site Albuquerque New Mexico United States 87102
    82 GSK Investigational Site Mineola New York United States 11501
    83 GSK Investigational Site New York New York United States 10022
    84 GSK Investigational Site Rochester New York United States 14627
    85 GSK Investigational Site Asheville North Carolina United States 28801
    86 GSK Investigational Site Greensboro North Carolina United States 27403
    87 GSK Investigational Site Hickory North Carolina United States 28601
    88 GSK Investigational Site Raleigh North Carolina United States 27607
    89 GSK Investigational Site Winston-Salem North Carolina United States 27103
    90 GSK Investigational Site Centerville Ohio United States 45450
    91 GSK Investigational Site Cincinnati Ohio United States 45236
    92 GSK Investigational Site Dayton Ohio United States 46432
    93 GSK Investigational Site Perrysburg Ohio United States 43551
    94 GSK Investigational Site Eugene Oregon United States 97401
    95 GSK Investigational Site Medford Oregon United States 97504
    96 GSK Investigational Site Portland Oregon United States 97210
    97 GSK Investigational Site Salem Oregon United States 97301
    98 GSK Investigational Site Levittown Pennsylvania United States 19056
    99 GSK Investigational Site Pittsburgh Pennsylvania United States 15243
    100 GSK Investigational Site Reading Pennsylvania United States 19611
    101 GSK Investigational Site Cranston Rhode Island United States 02920
    102 GSK Investigational Site Greer South Carolina United States 29651
    103 GSK Investigational Site Kingsport Tennessee United States 37660
    104 GSK Investigational Site New Tazewell Tennessee United States 37824-1409
    105 GSK Investigational Site Austin Texas United States 78756
    106 GSK Investigational Site Corpus Christi Texas United States 78404
    107 GSK Investigational Site Galveston Texas United States 77555-0188
    108 GSK Investigational Site Houston Texas United States 77070
    109 GSK Investigational Site Richardson Texas United States 75080
    110 GSK Investigational Site San Antonio Texas United States 78217
    111 GSK Investigational Site San Antonio Texas United States 78229
    112 GSK Investigational Site Salt Lake City Utah United States 84107
    113 GSK Investigational Site Norfolk Virginia United States 23502
    114 GSK Investigational Site Richmond Virginia United States 23294
    115 GSK Investigational Site Spokane Washington United States 99207
    116 GSK Investigational Site Tacoma Washington United States 98405
    117 GSK Investigational Site Yakima Washington United States 98902
    118 GSK Investigational Site Charleston West Virginia United States 25304
    119 GSK Investigational Site La Crosse Wisconsin United States 54601
    120 GSK Investigational Site Broadmeadow New South Wales Australia 2292
    121 GSK Investigational Site Newcastle New South Wales Australia 2300
    122 GSK Investigational Site St Leonards New South Wales Australia 2065
    123 GSK Investigational Site Carina Heights Queensland Australia 4152
    124 GSK Investigational Site Kippa Ring Queensland Australia 4021
    125 GSK Investigational Site Bedford Park South Australia Australia 5042
    126 GSK Investigational Site Port Lincoln South Australia Australia 5606
    127 GSK Investigational Site Toorak Gardens South Australia Australia 5065
    128 GSK Investigational Site Box Hill Victoria Australia 3128
    129 GSK Investigational Site Carlton Victoria Australia 3053
    130 GSK Investigational Site Fremantle Western Australia Australia 6160
    131 GSK Investigational Site Nedlands Western Australia Australia 6009
    132 GSK Investigational Site Coquitlam British Columbia Canada V3K 3V9
    133 GSK Investigational Site Winnipeg Manitoba Canada R3A 1R9
    134 GSK Investigational Site Moncton New Brunswick Canada E1G 1A7
    135 GSK Investigational Site St. John's Newfoundland and Labrador Canada A1E 2C2
    136 GSK Investigational Site Mississauga Ontario Canada L4T 4J2
    137 GSK Investigational Site North Bay Ontario Canada P1B 2H3
    138 GSK Investigational Site North York Ontario Canada M2M 4E7
    139 GSK Investigational Site Sudbury Ontario Canada P3A 1Y8
    140 GSK Investigational Site Bonaventure Quebec Canada G0C 1E0
    141 GSK Investigational Site Saint Romuald Quebec Canada G6W 5M6
    142 GSK Investigational Site Trois-Rivieres Quebec Canada G8Z 1Y2
    143 GSK Investigational Site Boulogne France 92100
    144 GSK Investigational Site Grenoble France 38000
    145 GSK Investigational Site Montpellier Cedex 5 France 34295
    146 GSK Investigational Site Paris Cedex 4 France 75181
    147 GSK Investigational Site Paris France 75010
    148 GSK Investigational Site Paris France 75012
    149 GSK Investigational Site Budapest Hungary 1083
    150 GSK Investigational Site Budapest Hungary 1183
    151 GSK Investigational Site Csongrád Hungary 6640
    152 GSK Investigational Site Heves Hungary 3360
    153 GSK Investigational Site Alkmaar Netherlands 1815 JD
    154 GSK Investigational Site Breda Netherlands 4819 EV
    155 GSK Investigational Site Roosendaal Netherlands 4708 AE
    156 GSK Investigational Site Rotterdam Netherlands 3083 AN
    157 GSK Investigational Site Utrecht Netherlands 3584 CX
    158 GSK Investigational Site Christchurch New Zealand
    159 GSK Investigational Site Hamilton New Zealand 2001
    160 GSK Investigational Site Tauranga New Zealand 3001
    161 GSK Investigational Site Oslo Norway N-0027
    162 GSK Investigational Site Oslo Norway N-0260
    163 GSK Investigational Site Paradis Norway 5231
    164 GSK Investigational Site Rådahl Norway 5235
    165 GSK Investigational Site Skien Norway N-3710
    166 GSK Investigational Site Athlone, Cape Town South Africa 7760
    167 GSK Investigational Site Erasmuskloof, Pretoria South Africa 0048
    168 GSK Investigational Site Fourways, Johannesburg South Africa
    169 GSK Investigational Site Kempton Park South Africa 1620
    170 GSK Investigational Site Kenilworth, Cape Town South Africa 7708
    171 GSK Investigational Site Lynnwood, Pretoria South Africa 0040
    172 GSK Investigational Site Tygervalley South Africa 7536
    173 GSK Investigational Site Westridge, Mitchells Plain South Africa 7798
    174 GSK Investigational Site Alcorcon Spain 28922
    175 GSK Investigational Site Barcelona Spain 08003
    176 GSK Investigational Site El Ferrol Spain
    177 GSK Investigational Site Granada Spain 18012
    178 GSK Investigational Site Madrid Spain 28006
    179 GSK Investigational Site Madrid Spain 28034
    180 GSK Investigational Site Santander Spain 39008
    181 GSK Investigational Site Valencia Spain 46014
    182 GSK Investigational Site Jönköping Sweden SE-551 85
    183 GSK Investigational Site Karlstad Sweden SE-651 85
    184 GSK Investigational Site Linköping Sweden SE-581 85
    185 GSK Investigational Site Stockholm Sweden SE-141 86
    186 GSK Investigational Site Bern Switzerland 3011
    187 GSK Investigational Site Nottwil Switzerland 6207

    Sponsors and Collaborators

    • Cubist Pharmaceuticals LLC
    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, MD, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cubist Pharmaceuticals LLC
    ClinicalTrials.gov Identifier:
    NCT00259922
    Other Study ID Numbers:
    • SB-767905/013
    First Posted:
    Dec 1, 2005
    Last Update Posted:
    Sep 2, 2015
    Last Verified:
    Sep 1, 2009
    Keywords provided by Cubist Pharmaceuticals LLC
    constipation
    gastrointestinal
    opioids
    pain
    non-cancer pain
    opioid-induced
    bowel dysfunction
    Additional relevant MeSH terms:
    Intestinal Diseases
    Gastrointestinal Diseases
    Constipation
    Alvimopan

    Study Results

    No Results Posted as of Sep 2, 2015