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Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Sponsor
Cubist Pharmaceuticals LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00101998
Collaborator
GlaxoSmithKline (Industry)
233
Enrollment
162
Locations
4
Arms
31
Actual Duration (Months)
1.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
233 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Actual Study Start Date :
Oct 1, 2003
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
May 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alvimopan 0.5 mg Twice Daily (BID)

0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.

Drug: alvimopan
Experimental: Alvimopan 1 mg Once Daily (QD)

0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.

Drug: alvimopan

Drug: placebo
Experimental: Alvimopan 1 mg Twice Daily (BID)

0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Drug: alvimopan
Placebo Comparator: Placebo

Placebo was administered orally BID for 3 weeks.

Drug: placebo

Outcome Measures

Primary Outcome Measures

  1. Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum. []

Secondary Outcome Measures

  1. Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use. []

Eligibility Criteria

Criteria

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

  • Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.

  • Participant is taking opioid therapy for persistent cancer pain.

  • Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].

  • Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.

  • Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

Exclusion criteria:

  • Participant is pregnant or lactating, or planning to become pregnant.

  • Participant is not ambulatory.

  • Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.

  • Participant is unable to eat, drink, take/hold down oral medications.

  • Participant is taking opioids for the management of drug addiction.

  • Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.

  • Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.

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

  • Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.

  • Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.

  • Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Tucson Arizona United States 85723
2 GSK Investigational Site Hot Springs Arkansas United States 71913
3 GSK Investigational Site Duarte California United States 91010
4 GSK Investigational Site Fountain Valley California United States 92708
5 GSK Investigational Site Fresno California United States 93720
6 GSK Investigational Site La Verne California United States 91750
7 GSK Investigational Site Los Angeles California United States 90057
8 GSK Investigational Site Los Gatos California United States 95032
9 GSK Investigational Site Modesto California United States 95355
10 GSK Investigational Site Sacramento California United States 95819
11 GSK Investigational Site San Diego California United States 92103
12 GSK Investigational Site San Diego California United States 92120
13 GSK Investigational Site Santa Monica California United States 90403
14 GSK Investigational Site Denver Colorado United States 80210
15 GSK Investigational Site Washington, D.C. District of Columbia United States 20007
16 GSK Investigational Site Washington, D.C. District of Columbia United States 20010
17 GSK Investigational Site Gainesville Florida United States 32604
18 GSK Investigational Site Inverness Florida United States 34452
19 GSK Investigational Site Lecanto Florida United States 34461
20 GSK Investigational Site Miami Shores Florida United States 33138
21 GSK Investigational Site New Port Richey Florida United States 34652
22 GSK Investigational Site New Port Richey Florida United States 34653
23 GSK Investigational Site Ocala Florida United States 34474
24 GSK Investigational Site Palm Harbor Florida United States 34684
25 GSK Investigational Site Stuart Florida United States 34996
26 GSK Investigational Site Tampa Florida United States 33612-9497
27 GSK Investigational Site Titusville Florida United States 32796
28 GSK Investigational Site Decatur Georgia United States 30033
29 GSK Investigational Site Chicago Illinois United States 60610
30 GSK Investigational Site West Des Moines Iowa United States 50265
31 GSK Investigational Site Hutchinson Kansas United States 67502
32 GSK Investigational Site Baltimore Maryland United States 21218
33 GSK Investigational Site Baltimore Maryland United States 21229-5299
34 GSK Investigational Site Baltimore Maryland United States 21239
35 GSK Investigational Site Bethesda Maryland United States 20817
36 GSK Investigational Site Boston Massachusetts United States 02115
37 GSK Investigational Site Boston Massachusetts United States 02215
38 GSK Investigational Site Worcester Massachusetts United States 01608
39 GSK Investigational Site Ann Arbor Michigan United States 48109
40 GSK Investigational Site Flint Michigan United States 48503
41 GSK Investigational Site Saint Louis Park Minnesota United States 55426
42 GSK Investigational Site Kansas City Missouri United States 64114
43 GSK Investigational Site Saint Louis Missouri United States 63141
44 GSK Investigational Site Reno Nevada United States 89502
45 GSK Investigational Site Albuquerque New Mexico United States 87109
46 GSK Investigational Site Bethpage New York United States 11714
47 GSK Investigational Site Huntington Station New York United States 11746
48 GSK Investigational Site Jamaica New York United States 11432
49 GSK Investigational Site Chapel Hill North Carolina United States 27599
50 GSK Investigational Site Charlotte North Carolina United States 28209
51 GSK Investigational Site Durham North Carolina United States 27710
52 GSK Investigational Site Hendersonville North Carolina United States 28793
53 GSK Investigational Site Raleigh North Carolina United States 27606
54 GSK Investigational Site Winston-Salem North Carolina United States 27103
55 GSK Investigational Site Bismarck North Dakota United States 58501
56 GSK Investigational Site Bismarck North Dakota United States 58503
57 GSK Investigational Site Canton Ohio United States 44718
58 GSK Investigational Site Middletown Ohio United States 45042
59 GSK Investigational Site Portland Oregon United States 97225
60 GSK Investigational Site Nashville Tennessee United States 37232
61 GSK Investigational Site Amarillo Texas United States 79106
62 GSK Investigational Site Houston Texas United States 77030
63 GSK Investigational Site Webster Texas United States 77598
64 GSK Investigational Site Norfolk Virginia United States 23507
65 GSK Investigational Site Portsmouth Virginia United States 23704
66 GSK Investigational Site Richmond Virginia United States 23249
67 GSK Investigational Site Richmond Virginia United States 23298-5028
68 GSK Investigational Site Tacoma Washington United States 98405
69 GSK Investigational Site Milwaukee Wisconsin United States 53215
70 GSK Investigational Site Capital Federal Buenos Aires Argentina C1405CUB
71 GSK Investigational Site Rosario Santa Fe Argentina 2000
72 GSK Investigational Site St Leonards New South Wales Australia 2065
73 GSK Investigational Site Redcliffe Queensland Australia 4020
74 GSK Investigational Site South Brisbane Queensland Australia 4101
75 GSK Investigational Site Daw Park South Australia Australia 5041
76 GSK Investigational Site Malvern Victoria Australia 3144
77 GSK Investigational Site Winnipeg Manitoba Canada R3A 1R9
78 GSK Investigational Site Saint John's Newfoundland and Labrador Canada A1B 3V6
79 GSK Investigational Site Kitchener Ontario Canada N2G 1G3
80 GSK Investigational Site London Ontario Canada N6A 4L6
81 GSK Investigational Site North Bay Ontario Canada P1B 2H3
82 GSK Investigational Site Oshawa Ontario Canada L1G 2B9
83 GSK Investigational Site Sudbury Ontario Canada P3E 5J1
84 GSK Investigational Site Bonaventure Quebec Canada G0C 1E0
85 GSK Investigational Site Chandler Quebec Canada G0C 1K0
86 GSK Investigational Site Levis Quebec Canada G6V 3Z1
87 GSK Investigational Site Montreal Quebec Canada H1T 2M4
88 GSK Investigational Site Sherbrooke Quebec Canada J1H 1Z1
89 GSK Investigational Site Quebec Canada G1R 2J6
90 GSK Investigational Site Brno Czechia 625 00
91 GSK Investigational Site Brno Czechia 656 91
92 GSK Investigational Site Plzen Czechia 304 60
93 GSK Investigational Site Praha 10 Czechia 100 34
94 GSK Investigational Site Helsinki Finland 00029
95 GSK Investigational Site Bordeaux Cedex France 33076
96 GSK Investigational Site Vandoeuvre-Les-Nancy France 54511
97 GSK Investigational Site Villejuif Cedex France 94805
98 GSK Investigational Site Goettingen Niedersachsen Germany 37073
99 GSK Investigational Site Goslar Niedersachsen Germany 38642
100 GSK Investigational Site Kwun Tong Hong Kong
101 GSK Investigational Site Pokfulam Hong Kong
102 GSK Investigational Site Shatin Hong Kong
103 GSK Investigational Site Budapest Hungary 1097
104 GSK Investigational Site Budapest Hungary 1529
105 GSK Investigational Site Miskolc Hungary 3529
106 GSK Investigational Site Zalaegerszeg-Pozva Hungary 8900
107 GSK Investigational Site Bangalore India 560 034
108 GSK Investigational Site Caserta Campania Italy 81100
109 GSK Investigational Site Napoli Campania Italy 80131
110 GSK Investigational Site Forlì Emilia-Romagna Italy 47100
111 GSK Investigational Site Rimini Emilia-Romagna Italy 47900
112 GSK Investigational Site Genova Liguria Italy 16132
113 GSK Investigational Site Milano Lombardia Italy 20127
114 GSK Investigational Site Pavia Lombardia Italy 27100
115 GSK Investigational Site Busca (CN) Piemonte Italy 12022
116 GSK Investigational Site Novara Piemonte Italy 28100
117 GSK Investigational Site Catania Sicilia Italy 95124
118 GSK Investigational Site Firenze Toscana Italy 50139
119 GSK Investigational Site Seoul Korea, Republic of 137-701
120 GSK Investigational Site Seoul Korea, Republic of 152-703
121 GSK Investigational Site Leeuwarden Netherlands 8934 AD
122 GSK Investigational Site Dunedin New Zealand 9001
123 GSK Investigational Site Hastings New Zealand 4201
124 GSK Investigational Site Wellington New Zealand 6002
125 GSK Investigational Site Lahore Pakistan 54600
126 GSK Investigational Site Lima Peru Lima 11
127 GSK Investigational Site Lima Peru Lima 34
128 GSK Investigational Site Manila Philippines 1000
129 GSK Investigational Site Bialystok Poland 15-540
130 GSK Investigational Site Olsztyn Poland 10-228
131 GSK Investigational Site Otwock Poland 05-400
132 GSK Investigational Site Poznan Poland 60-569
133 GSK Investigational Site Lisboa Portugal 1069-166 Lisboa
134 GSK Investigational Site Lisboa Portugal 1070
135 GSK Investigational Site Lisboa Portugal 1800
136 GSK Investigational Site Moscow Russian Federation 117216
137 GSK Investigational Site Moscow Russian Federation 119048
138 GSK Investigational Site Moscow Russian Federation 127018
139 GSK Investigational Site St'Petersburg Russian Federation 195247
140 GSK Investigational Site Durban KwaZulu- Natal South Africa 4001
141 GSK Investigational Site Groenkloof, Pretoria South Africa
142 GSK Investigational Site Houghton, Johannesburg South Africa 2000
143 GSK Investigational Site Kenilworth, Cape Town South Africa 7745
144 GSK Investigational Site Alcorcon Spain 28922
145 GSK Investigational Site Barcelona Spain 08023
146 GSK Investigational Site Barcelona Spain 08036
147 GSK Investigational Site Cordoba Spain 14004
148 GSK Investigational Site Granada Spain 18012
149 GSK Investigational Site Jaén Spain 23007
150 GSK Investigational Site Madrid Spain 28006
151 GSK Investigational Site Sabadell / Barcelona Spain
152 GSK Investigational Site Serra / Valencia Spain
153 GSK Investigational Site Sevilla Spain 41014
154 GSK Investigational Site Soria Spain 42002
155 GSK Investigational Site Valencia Spain 46010
156 GSK Investigational Site Taipei Taiwan 100
157 GSK Investigational Site Chiang Mai Thailand 50200
158 GSK Investigational Site London United Kingdom SW3 6JJ
159 GSK Investigational Site Newcastle-upon-Tyne United Kingdom NE4 6BE
160 GSK Investigational Site Nottingham United Kingdom NG5 1PB
161 GSK Investigational Site Sheffield United Kingdom S10 2JF
162 GSK Investigational Site Surrey United Kingdom SM2 5PT

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:
NCT00101998
Other Study ID Numbers:
  • 3753-009
  • 767905/008
  • NCT00903513
First Posted:
Jan 19, 2005
Last Update Posted:
Aug 30, 2017
Last Verified:
Aug 1, 2017
Keywords provided by Cubist Pharmaceuticals LLC
OBD (Induced Bowel Dysfunction)
cancer pain
pain medication
constipation
bowel
bowel dysfunction
Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Constipation
Alvimopan

Study Results

No Results Posted as of Aug 30, 2017