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Polyethylene Glycol Derivative

B for Constipation

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 through 28
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.

Eligible Conditions
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 through 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 through 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
Secondary study objectives
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Change From Baseline in SBMs/Week Across the 28-day Double-blind Period

Side effects data

From 2012 Phase 3 trial • 844 Patients • NCT01336205
18%
ABDOMINAL PAIN
14%
DIARRHOEA
10%
NAUSEA
9%
BACK PAIN
9%
HEADACHE
7%
FLATULENCE
6%
ABDOMINAL PAIN UPPER
6%
ARTHRALGIA
6%
BRONCHITIS
6%
NASOPHARYNGITIS
6%
UPPER RESPIRATORY TRACT INFECTION
5%
URINARY TRACT INFECTION
5%
VOMITING
5%
COUGH
4%
FALL
4%
PAIN IN EXTREMITY
4%
SINUSITIS
3%
FATIGUE
3%
PYREXIA
3%
NASAL CONGESTION
3%
MUSCLE SPASMS
3%
HYPERTENSION
3%
GASTROENTERITIS VIRAL
3%
ANXIETY
3%
INSOMNIA
3%
HYPERHIDROSIS
2%
CHILLS
2%
DIZZINESS
2%
ABDOMINAL DISCOMFORT
2%
ABDOMINAL DISTENSION
2%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
OEDEMA PERIPHERAL
2%
CONTUSION
2%
INFLUENZA
2%
DEPRESSION
1%
DEHYDRATION
1%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%
HYPERCHOLESTEROLAEMIA
1%
PNEUMONIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
NKTR-118 25 mg
Usual Care

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BExperimental Treatment1 Intervention
NKTR-118
Group II: APlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxegol
FDA approved

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsIndustry Sponsor
58 Previous Clinical Trials
10,109 Total Patients Enrolled
AstraZenecaLead Sponsor
4,408 Previous Clinical Trials
289,121,862 Total Patients Enrolled
19 Trials studying Constipation
5,875 Patients Enrolled for Constipation
Mark SostekStudy DirectorAstraZeneca Pharmaceuticals, Wilm DE
5 Previous Clinical Trials
2,526 Total Patients Enrolled
4 Trials studying Constipation
2,498 Patients Enrolled for Constipation
~11 spots leftby Dec 2025
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