Trial · NCT01928381

Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability

NCT01928381, Phase 2, Completed, AstraZeneca; results first posted 2016-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability. Trials, record NCT01928381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928381

On this page

Trial

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

Title: Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability
NCT number: NCT01928381
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: AstraZeneca
Conditions: Diabetic Neuropathy, Painful; Diabetic Neuropathies
Interventions: AZD5213 + pregabalin, Placebo, pregabalin capsules
First posted: 2013-08-23
Last updated: 2016-10-03
Results first posted: 2016-10-03

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain	3 weeks of treatment	Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain	3 weeks of treatment	Full Analysis set	Average daily pain score	LEAST_SQUARES_MEAN
POST_HOC	Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol	3 weeks of treatment	Per Protocol	Average daily pain score	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain	Part 2 - Placebo	4.24	Standard Error 0.38	Average daily pain score
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain	Part 2 - Pregabalin + AZD5213	4.41	Standard Error 0.38	Average daily pain score
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain	Part 2 - Pregabalin	4.27	Standard Error 0.38	Average daily pain score
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol	Part 2 - Placebo	4.46	Standard Error 0.45	Average daily pain score
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol	Part 2 - Pregabalin + AZD5213	4.35	Standard Error 0.45	Average daily pain score
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol	Part 2 - Pregabalin	4.04	Standard Error 0.45	Average daily pain score

Source ClinicalTrials.gov

Participant flow189

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

Period	Milestone	Group	Participants
Screening for Pain Training	STARTED	Part 1 - Pain Training	143
Screening for Pain Training	STARTED	Sequence 1	0
Screening for Pain Training	STARTED	Sequence 2	0
Screening for Pain Training	STARTED	Sequence 3	0
Screening for Pain Training	STARTED	Sequence 4	0
Screening for Pain Training	STARTED	Sequence 5	0
Screening for Pain Training	STARTED	Sequence 6	0
Screening for Pain Training	COMPLETED	Part 1 - Pain Training	83
Screening for Pain Training	COMPLETED	Sequence 1	0
Screening for Pain Training	COMPLETED	Sequence 2	0

1 to 10 of 189Source ClinicalTrials.gov

See all 189 participant flow

Adverse events270

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	Insomnia	Psychiatric disorders	Part 1	0	83	0
other	Insomnia	Psychiatric disorders	Part 2 - Placebo	1	30	1
other	Insomnia	Psychiatric disorders	Part 2 - Pregabalin + AZD5213	0	28	0
other	Insomnia	Psychiatric disorders	Part 2 - Pregabalin	1	30	1
other	Insomnia	Psychiatric disorders	Overall Study	1	83	2
other	Anxiety	Psychiatric disorders	Part 1	0	83	0
other	Anxiety	Psychiatric disorders	Part 2 - Placebo	0	30	0
other	Anxiety	Psychiatric disorders	Part 2 - Pregabalin + AZD5213	0	28	0
other	Anxiety	Psychiatric disorders	Part 2 - Pregabalin	1	30	1
other	Anxiety	Psychiatric disorders	Overall Study	1	83	1

1 to 10 of 270Source ClinicalTrials.gov

See all 270 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1
Total, all-cause mortality	Part 2 - Placebo
Total, all-cause mortality	Part 2 - Pregabalin + AZD5213
Total, all-cause mortality	Part 2 - Pregabalin
Total, all-cause mortality	Overall Study
Total, other adverse events	Part 1	19	83
Total, other adverse events	Part 2 - Placebo	8	30
Total, other adverse events	Part 2 - Pregabalin + AZD5213	11	28
Total, other adverse events	Part 2 - Pregabalin	11	30
Total, other adverse events	Overall Study	32	83

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT01928381

GET https://conductscience.org/api/trials/v1/NCT01928381/flow?page=2

API reference For AI assistants