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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alvimopan 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.
Placebo Perioperative administration of placebo, at same dosing interval as study drug.

Participant Flow:   Overall Study
    Alvimopan   Placebo
STARTED   71   75 
COMPLETED   66   68 
NOT COMPLETED   5   7 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are provided for the subjects who completed study follow up.

Reporting Groups
  Description
Alvimopan 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.
Placebo Perioperative administration of placebo, at same dosing interval as study drug.
Total Total of all reporting groups

Baseline Measures
   Alvimopan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 66   68   134 
Age 
[Units: Years]
Mean (Standard Deviation) 		 60.4  (10.2)   63.7  (11.2)   62.1  (10.8) 
Gender 
[Units: Participants]
 		     
Female   66   68   134 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
 		     
United States   66   68   134 
Surgery Type 
[Units: Participants]
 		     
Primary surgery   45   46   91 
Interval debulking   9   11   20 
Secondary debulking   12   11   23 
Cancer Stage [1] 
[Units: 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] 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 
[Units: 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 


  Outcome Measures

1.  Primary:   Postoperative Length of Hospital Stay   [ Time Frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days ]
  Show Outcome Measure 1

2.  Secondary:   Postoperative Ileus Incidence   [ Time Frame: Patients will be followed for 30 days postop ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Bakkum.Jamie@mayo.edu



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