Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients

NCT02946580 | Terminated Phase 4 Results DMC

• 2 other identifiers: 2016P001847ESR-15-11338, D3820L00008
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Time to First Post-operative Spontaneous Bowel Movement

  The primary endpoint of the study was time to first post-operative bowel movement, as defined by the first spontaneous bowel movement reported by nursing staff after transfer from the surgical suite to the inpatient floor. A bowel movement was defined as the spontaneous passage of one tablespoon or more of liquid or solid stool (excluding flatus), which could be measured and verified by nursing staff. Time was measured in hours post-operatively with the starting time point marked at the end of the surgical procedure.

  through study completion, an average of 6 days

Secondary Outcomes (5)

• Time to Rescue Laxative Medication Use During Hospitalization

  upon discharge from hospital, an average of 5 days

• Length of Stay

  through study completion, an average of 6 days

• Patient's Satisfaction With Their Bowels by Use of the Bowel Function Index

  through study completion, an average of 6 days

• Patient's Satisfaction With Their Bowels at Discharge Using a 5-point Likert Scale.

  upon discharge from hospital, an average of 5 days

• Number of Participants That Experienced Diarrhea

  through study completion, an average of 6 days

Study Arms (2)

MOVANTIK™ (naloxegol)

EXPERIMENTAL

Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing). Subjects with renal impairments (creatine clearance rate of less than 60 mL/min) will receive a 12.5 mg dose tablet of naloxegol in place of the 25 mg dose as advised by FDA guidelines. For patients who are unable to swallow the tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube.

Drug: MOVANTIK™ (naloxegol)

Sugar pill

PLACEBO COMPARATOR

Matching placebo consists of an inert mixture supplied by AstraZeneca in identical-appearing tablets. Subjects in the placebo group will be administered a placebo tablet once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing).

Drug: Sugar Pill

Interventions

MOVANTIK™ (naloxegol) DRUG

MOVANTIK™ (naloxegol)

Sugar Pill DRUG

Sugar pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between the ages of 18 and 75 years undergoing non-urgent, elective spinal fusion at Massachusetts General Hospital who are admitted to the neurosurgery floor from the operating room

You may not qualify if:

• Patients who are taken to the operating room from another inpatient floor or service (already hospitalized prior to surgery)
• Patients with evidence of bowel obstruction
• Patients unable to take oral medications by mouth or by enteric feeding tube (gastrostomy or jejunostomy)
• Patients with a documented or potential allergy or adverse reaction to Movantik (naloxegol) from outpatient use
• Patients currently taking Movantik (naloxegol) in the outpatient setting
• Patients with a preoperative diagnosis of irritable bowel syndrome (IBS) obtained via Rome III questionnaire on screening
• Patients with disruptions to the blood-brain barrier (eg, multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy)
• Patients with a history of cancer.
• Patients concomitantly using strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole), strong CYP3A4 inducers and other opioid antagonists.
• Patients with severe hepatic impairment.
• Patients with a previous history of or risk of bowel perforation.
• Patients with a post-op regional anesthetic technique employed like a continuous epidural or spinal.
• Patients for which local anesthetics will be placed in the wound.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

naloxegol; Sugars

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Kyle Staller
• Organization: Massachusetts General Hospital

kstaller@mgh.harvard.edu

617-724-7556

Study Officials

• Kyle Staller, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 27, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)