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

Participant Flow

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
Arm/Group Description	Perioperative administration of ora...	Perioperative administration of pla...
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

Baseline Characteristics

Arm/Group Title		Alvimopan	Placebo	Total
Arm/Group Description		Perioperative administration of ora...	Perioperative administration of pla...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		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

Outcome Measures

1.Primary Outcome

Title	Postoperative Length of Hospital Stay
Description	Length of stay = date/time of hospital dismissal - date/time of end of...
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

Outcome Measure Data

Analysis Population Description

Intent to Treat analysis


Arm/Group Title	Alvimopan	Placebo
Arm/Group Description:	Perioperative administration of ora...	Perioperative administration of pla...
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)

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
Description	Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) st...
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

Outcome Measure Data

Analysis Population Description

Intent to treat analysis


Arm/Group Title	Alvimopan	Placebo
Arm/Group Description:	Perioperative administration of ora...	Perioperative administration of pla...
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

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]

Adverse Events

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
Arm/Group Description	Perioperative administration of ora...		Perioperative administration of ora...
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	--/--		--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

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

EMail: 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

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