Trial · NCT01336205

Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

NCT01336205, Phase 3, Completed, AstraZeneca; results first posted 2014-10-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation. Trials, record NCT01336205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01336205

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
NCT number: NCT01336205
Status: Completed
Phases: Phase 3
Enrollment: 844 participants, actual
Lead sponsor: AstraZeneca
Conditions: Opioid-Induced Constipation (OIC)
Interventions: NKTR-118, Usual care
First posted: 2011-04-15
Last updated: 2014-10-20
Results first posted: 2014-10-20

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Patients Experiencing at Least One Adverse Event (AE)	Baseline (Week 0) to end of the follow-up period	The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Primary	Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)	Baseline (Week 0) to end of the follow-up period	The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Primary	Incidence of Patients Experiencing Severe Adverse Events (SAEs)	Baseline (Week 0) to end of the follow-up period	The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Patients Experiencing at Least One Adverse Event (AE)	Baseline (Week 0) to end of the follow-up period	The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.	Participants	NUMBER
PRIMARY	Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)	Baseline (Week 0) to end of the follow-up period	The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.	Participants	NUMBER
PRIMARY	Incidence of Patients Experiencing Severe Adverse Events (SAEs)	Baseline (Week 0) to end of the follow-up period	The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Incidence of Patients Experiencing at Least One Adverse Event (AE)	NKTR-118 25 mg	437	Participants
Incidence of Patients Experiencing at Least One Adverse Event (AE)	Usual Care	195	Participants
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)	NKTR-118 25 mg	56	Participants
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)	Usual Care	NA	Participants
Incidence of Patients Experiencing Severe Adverse Events (SAEs)	NKTR-118 25 mg	51	Participants
Incidence of Patients Experiencing Severe Adverse Events (SAEs)	Usual Care	30	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NKTR-118 25 mg	563
Overall Study	STARTED	Usual Care	281
Overall Study	COMPLETED	NKTR-118 25 mg	330
Overall Study	COMPLETED	Usual Care	192
Overall Study	NOT COMPLETED	NKTR-118 25 mg	233
Overall Study	NOT COMPLETED	Usual Care	89

Source ClinicalTrials.gov

Adverse events264

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	NKTR-118 25 mg	13	534	13
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Usual Care	1	270	1
other	ABDOMINAL DISTENSION	Gastrointestinal disorders	NKTR-118 25 mg	12	534	12
other	ABDOMINAL DISTENSION	Gastrointestinal disorders	Usual Care	3	270	3
other	ABDOMINAL PAIN	Gastrointestinal disorders	NKTR-118 25 mg	98	534	98
other	ABDOMINAL PAIN	Gastrointestinal disorders	Usual Care	9	270	9
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	NKTR-118 25 mg	30	534	30
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Usual Care	3	270	3
other	DIARRHOEA	Gastrointestinal disorders	NKTR-118 25 mg	73	534	73
other	DIARRHOEA	Gastrointestinal disorders	Usual Care	16	270	16

1 to 10 of 264Source ClinicalTrials.gov

See all 264 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NKTR-118 25 mg
Total, all-cause mortality	Usual Care
Total, other adverse events	NKTR-118 25 mg	365	534
Total, other adverse events	Usual Care	152	270
Total, serious adverse events	NKTR-118 25 mg	51	534
Total, serious adverse events	Usual Care	30	270

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25112584	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NKTR-118 25 mg vs Usual Care: Incidence of Patients Experiencing Severe Adverse Events (SAEs)	Trial comparisons
NKTR-118 25 mg vs Usual Care: Incidence of Patients Experiencing at Least One Adverse Event (AE)	Trial comparisons
NKTR-118 25 mg vs Usual Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01336205

GET https://conductscience.org/api/trials/v1/NCT01336205/events?page=2

API reference For AI assistants