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Accelerating Gastrointestinal Recovery

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ClinicalTrials.gov Identifier: NCT01704651
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Jamie N. Bakkum-Gamez, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Interventions Drug: Alvimopan
Drug: Placebo
Enrollment 146
Recruitment Details The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.
Pre-assignment Details  
Arm/Group Title Alvimopan Placebo
Hide Arm/Group Description Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. Perioperative administration of placebo, at same dosing interval as study drug.
Period Title: Overall Study
Started 71 75
Completed 66 68
Not Completed 5 7
Reason Not Completed
Pre-op withdrawal by subject             1             1
Pre-op change in treatment plan             1             4
Nasogastric tube placement in surgery             1             1
Post-op did not have laparotomy             2             1
Arm/Group Title Alvimopan Placebo Total
Hide Arm/Group Description Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. Perioperative administration of placebo, at same dosing interval as study drug. Total of all reporting groups
Overall Number of Baseline Participants 66 68 134
Hide Baseline Analysis Population Description
Baseline characteristics are provided for the subjects who completed study follow up.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 68 participants 134 participants
60.4  (10.2) 63.7  (11.2) 62.1  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
Female
66
 100.0%
68
 100.0%
134
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 68 participants 134 participants
66 68 134
Surgery Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
Primary surgery 45 46 91
Interval debulking 9 11 20
Secondary debulking 12 11 23
Cancer Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
I/II 17 8 25
III/IV 33 40 73
Other non-ovarian primary cancers 2 3 5
Benign pelvic masses 2 6 8
Recurrent disease 12 11 23
[1]
Measure Description: Cancer Stage used the Fédération Internationale de Gynécologie et d’Obstétrique (FIGO) staging system. For ovarian cancer, there are 4 stages: stage I: confined to the organ of origin, stage II: invasion of surrounding organs or tissue, stage III: spread to distant nodes or tissue within the pelvis, stage IV: distant metastasis(es)
Residual Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
No 48 50 98
Yes, measurable (</= 1 cm) 12 11 23
Yes, suboptimal (>1 cm, limited sites) 0 2 2
Yes, extensive (multiple sites/organs) 6 5 11
1.Primary Outcome
Title Postoperative Length of Hospital Stay
Hide Description Length of stay = date/time of hospital dismissal - date/time of end of surgery
Time Frame Patients will be followed for the duration of their hospital stay, an expected average of 5 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title Alvimopan Placebo
Hide Arm/Group Description:
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
Perioperative administration of placebo, at same dosing interval as study drug.
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: days
4.4  (2.7) 4.3  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Postoperative Ileus Incidence
Hide Description Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.
Time Frame Patients will be followed for 30 days postop
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Alvimopan Placebo
Hide Arm/Group Description:
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
Perioperative administration of placebo, at same dosing interval as study drug.
Overall Number of Participants Analyzed 66 68
Measure Type: Number
Unit of Measure: participants
7 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alvimopan Placebo
Hide Arm/Group Description Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
All-Cause Mortality
Alvimopan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alvimopan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/66 (13.64%)      10/68 (14.71%)    
Cardiac disorders     
Thromboembolic event  1  2/66 (3.03%)  2 2/68 (2.94%)  2
Hematoma  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Hypotension  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Gastrointestinal disorders     
Ascites  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Ileus  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Enterocolitis  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Nausea  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Metabolism and nutrition disorders     
Electrolyte Imbalance  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Malaise (Failure to thrive)  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Fluid Retention  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Sepsis  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Nervous system disorders     
Syncope  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Psychiatric disorders     
Mania  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Renal and urinary disorders     
Pelvic Fluid Collection  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Pleural Effusion  1  0/66 (0.00%)  0 3/68 (4.41%)  3
Respiratory Failure  1  0/66 (0.00%)  0 2/68 (2.94%)  2
Skin and subcutaneous tissue disorders     
Wound Dehiscence  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Wound Infection  1  2/66 (3.03%)  2 0/68 (0.00%)  0
Wound Complication  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alvimopan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/66 (78.79%)      57/68 (83.82%)    
Blood and lymphatic system disorders     
Leukocytosis  1  4/66 (6.06%)  4 2/68 (2.94%)  2
Thrombocytopenia  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Increased international normalized ratio (INR)  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Epistaxis  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Lymphedema  1  5/66 (7.58%)  5 6/68 (8.82%)  6
Lymphangitis  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Cardiac disorders     
Anemia  1  25/66 (37.88%)  25 27/68 (39.71%)  27
Arrhythmias  1  1/66 (1.52%)  1 5/68 (7.35%)  5
Hypotension  1  0/66 (0.00%)  0 2/68 (2.94%)  2
Hypertension  1  3/66 (4.55%)  3 1/68 (1.47%)  1
Thromboembolic event  1  0/66 (0.00%)  0 3/68 (4.41%)  3
Pulmonary Edema  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Gastrointestinal disorders     
Ascites  1  2/66 (3.03%)  2 6/68 (8.82%)  6
Biliary Leak  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Bloating  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Constipation  1  18/66 (27.27%)  18 16/68 (23.53%)  16
Dehydration  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Diarrhea  1  6/66 (9.09%)  6 3/68 (4.41%)  3
Dysphagia  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Dyspepsia  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Ileus  1  7/66 (10.61%)  7 12/68 (17.65%)  12
Nausea  1  20/66 (30.30%)  20 10/68 (14.71%)  10
Vomiting  1  9/66 (13.64%)  9 8/68 (11.76%)  8
Anorexia  1  4/66 (6.06%)  4 2/68 (2.94%)  2
Esophagitis  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Gastroparesis  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Enterocolitis  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Small Bowel Obstruction  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Small Bowel Perforation  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Weight Loss  1  3/66 (4.55%)  3 1/68 (1.47%)  1
General disorders     
Allergic reaction to chemo  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Metabolism and nutrition disorders     
Electrolyte Imbalance  1  8/66 (12.12%)  8 7/68 (10.29%)  7
Hypomagnesemia  1  2/66 (3.03%)  2 0/68 (0.00%)  0
Elevated Liver Enzymes  1  2/66 (3.03%)  2 0/68 (0.00%)  0
Fatigue  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Nervous system disorders     
Syncope  1  2/66 (3.03%)  2 4/68 (5.88%)  4
Generalized Muscle Weakness  1  2/66 (3.03%)  2 3/68 (4.41%)  3
Delirium  1  3/66 (4.55%)  3 0/68 (0.00%)  0
Somnolence  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Tinnitus  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Insomnia  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Neuropathy, sensory  1  3/66 (4.55%)  3 1/68 (1.47%)  1
Pain  1  6/66 (9.09%)  6 6/68 (8.82%)  6
Anxiety  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Renal and urinary disorders     
Acute Kidney Injury  1  1/66 (1.52%)  1 4/68 (5.88%)  4
Cystotomy  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Pelvic Abscess  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Urinary Tract Infection  1  7/66 (10.61%)  7 8/68 (11.76%)  8
Urinary Incontinence  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Hematuria  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Urinary Tract Obstruction  1  1/66 (1.52%)  1 0/68 (0.00%)  0
Bladder Symptoms  1  6/66 (9.09%)  6 3/68 (4.41%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/66 (1.52%)  1 1/68 (1.47%)  1
Dyspnea  1  4/66 (6.06%)  4 5/68 (7.35%)  5
Pleural Effusion  1  5/66 (7.58%)  5 5/68 (7.35%)  5
Pneumonitis  1  2/66 (3.03%)  2 0/68 (0.00%)  0
Pneumonthorax  1  2/66 (3.03%)  2 1/68 (1.47%)  1
Skin and subcutaneous tissue disorders     
Wound Infection  1  7/66 (10.61%)  7 3/68 (4.41%)  3
Wound Complication  1  4/66 (6.06%)  4 5/68 (7.35%)  5
Vaginal Infection  1  0/66 (0.00%)  0 2/68 (2.94%)  2
Blepharitis  1  0/66 (0.00%)  0 1/68 (1.47%)  1
Dermatitis  1  2/66 (3.03%)  2 2/68 (2.94%)  2
Skin Infection  1  2/66 (3.03%)  2 1/68 (1.47%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jamie N. Bakkum-Gamez
Organization: Mayo Clinic
Phone: 507-266-8661
Responsible Party: Jamie N. Bakkum-Gamez, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01704651     History of Changes
Other Study ID Numbers: 12-004082
First Submitted: October 7, 2012
First Posted: October 11, 2012
Results First Submitted: August 30, 2016
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016