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Mu-opioid receptor antagonist

2 for Constipation

Phase 3
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 baseline (week 1) to end of treatment (week 12)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

Eligible Conditions
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1) to end of treatment (week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1) to end of treatment (week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
Secondary study objectives
Change From Baseline in Degree of Straining
Change From Baseline in Mean Spontaneous Bowel Movements/Week
Constipation
+5 more

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment1 Intervention
Oral treatment
Group II: 1Experimental Treatment1 Intervention
Oral treatment
Group III: 3Placebo Group1 Intervention
Oral treatment
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?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,120,957 Total Patients Enrolled
19 Trials studying Constipation
5,382 Patients Enrolled for Constipation
Mark SostekStudy DirectorAstraZeneca
5 Previous Clinical Trials
2,033 Total Patients Enrolled
4 Trials studying Constipation
2,005 Patients Enrolled for Constipation
~48 spots leftby Nov 2025
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