A Study Evaluating Intravenous (IV) MOA-728 for the Treat... | NCT00528970

Status Module

Name	Class
Progenics Pharmaceuticals, Inc.	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MOA-728 12 mg	Experimental	Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.	Drug: MOA-728
MOA-728 24 mg	Experimental	Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.	Drug: MOA-728
Placebo	Placebo Comparator	Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MOA-728	Drug	MOA-728 will be administered per the dose and schedule specified in the arm.	MOA-728 12 mg MOA-728 24 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to First Bowel Movement	Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.	Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Secondary Outcomes

Measure	Description	Time Frame
Time to Discharge Eligibility	Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.	Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Eligibility Module

Name	Affiliation	Role
Lindsey Mathew	Bausch Health Americas, Inc.	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MOA-728 12 mg	Participants received methylnaltrexone (MOA-728) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	MOA-728 12 mg	Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
BG001	MOA-728 24 mg	Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
BG002	Placebo	Participants received placebo matched to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00093.3± 3.2 OG001100.4± 4.2 OG00291.3± 3.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.	Log Rank		0.944	Threshold for significance at 0.05 level.	Mean Difference (Final Values)	2.0											Other
OG001 OG002

Secondary

Time to Discharge Eligibility

Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.

mITT population included all randomized participants who received at least 1 dose of study drug.

Posted

Mean

Standard Error

hours

Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

ID	Title	Description
OG000	MOA-728 12 mg	Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
OG001	MOA-728 24 mg	Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.

Secondary

Time to Discharge Order Written From the End of Surgery

The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge was considered treatment failures. Analysis was performed by Kaplan-Meier estimate.

mITT population included all randomized participants who received at least 1 dose of study drug.

Posted

Mean

Standard Error

hours

Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

ID	Title	Description
OG000	MOA-728 12 mg	Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
OG001	MOA-728 24 mg	Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.

Secondary

Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at Day 2 (24 Hours) as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)

CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.

mITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Day 2

ID	Title	Description
OG000	MOA-728 12 mg	Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.
OG001	MOA-728 24 mg

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MOA-728 12 mg	Participants received MOA-728 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.	20	124	68	124
EG001	MOA-728 24 mg	Participants received MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.	17	125	71	125
EG002	Placebo	Participants received placebo matched to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug was administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple was placed in the participant). Dose administration was continued for a maximum of 10 days.	28	124	73	124

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0022 affected124 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0021 affected124 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0011 affected125 at risk EG0021 affected124 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0012 affected125 at risk EG0020 affected124 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0021 affected124 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Hernia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Wound necrosis	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0021 affected124 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Device related infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Incision site infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Post procedural infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Wound infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected124 at risk EG0010 affected125 at risk EG0022 affected124 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0012 affected125 at risk EG0020 affected124 at risk
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected124 at risk EG0011 affected125 at risk EG0022 affected124 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0022 affected124 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0023 affected124 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Liver function test abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0021 affected124 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0020 affected124 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0011 affected125 at risk EG0022 affected124 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected124 at risk EG0010 affected125 at risk EG0021 affected124 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected124 at risk EG0010 affected125 at risk EG0020 affected124 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected124 at risk EG0012 affected125 at risk EG0028 affected124 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected124 at risk EG00113 affected125 at risk EG00211 affected124 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00039 affected124 at risk EG00133 affected125 at risk EG00238 affected124 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00016 affected124 at risk EG00120 affected125 at risk EG00221 affected124 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected124 at risk EG0011 affected125 at risk EG0023 affected124 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected124 at risk EG00115 affected125 at risk EG00218 affected124 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected124 at risk EG00110 affected125 at risk EG0024 affected124 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected124 at risk EG0014 affected125 at risk EG0025 affected124 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected124 at risk EG0019 affected125 at risk EG00213 affected124 at risk
Somnolence	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected124 at risk EG0011 affected125 at risk EG0026 affected124 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected124 at risk EG00110 affected125 at risk EG00211 affected124 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected124 at risk EG00111 affected125 at risk EG00217 affected124 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected124 at risk EG0018 affected125 at risk EG0027 affected124 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Benton	Arkansas	72015	United States

ID	Term
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms