Trial · NCT02260388

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

NCT02260388, Phase 4, Completed, University of Kansas Medical Center; results first posted 2018-07-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations. Trials, record NCT02260388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02260388

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Trial

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

Title: Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
NCT number: NCT02260388
Status: Completed
Phases: Phase 4
Enrollment: 402 participants, actual
Lead sponsor: University of Kansas Medical Center
Conditions: Cryptogenic Sensory Polyneuropathy
Interventions: Nortriptyline, Duloxetine, Pregabalin, Mexiletine
First posted: 2014-10-09
Last updated: 2018-07-06
Results first posted: 2018-07-06

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	12 weeks	The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.
Secondary	SF12 Health Composite Scores	12 weeks	SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view. Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. Scores are calibrated so that 50 is the average score or norm, standard deviation = 10. Higher scores indicate better health for both mental and physical component summary scores.
Secondary	PROMIS Pain Interference Short Form v1.0 8a T Score	12 weeks	Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
Secondary	PROMIS Fatigue Short Form v1.0 8a	12 Weeks	Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
Secondary	PROMIS Sleep Disturbance Short Form v1.0 8a	12 weeks	Higher scores for sleep disturbance represents worse outcome (more sleep disturbance). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population. Higher scores equals more of the concept being measured

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	SF12 Health Composite Scores	12 weeks	No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.	Norm-Based Standardization Score	MEAN
SECONDARY	PROMIS Pain Interference Short Form v1.0 8a T Score	12 weeks	No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.	T-Score	MEAN
SECONDARY	PROMIS Fatigue Short Form v1.0 8a	12 Weeks	No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.	T-Score	MEAN
SECONDARY	PROMIS Sleep Disturbance Short Form v1.0 8a	12 weeks	No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.	T-Score	MEAN

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Units
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Nortriptyline	Efficacious and Non-Quit	34	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Duloxetine	Efficacious and Non-Quit	29	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Pregabalin	Efficacious and Non-Quit	11	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Mexiletine	Efficacious and Non-Quit	14	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Nortriptyline	Non-Efficacious and Non-Quit	49	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Duloxetine	Non-Efficacious and Non-Quit	50	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Pregabalin	Non-Efficacious and Non-Quit	31	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Mexiletine	Non-Efficacious and Non-Quit	15	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Nortriptyline	Quit	51	Participants
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit	Duloxetine	Quit	47	Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nortriptyline	134
Overall Study	STARTED	Duloxetine	126
Overall Study	STARTED	Pregabalin	73
Overall Study	STARTED	Mexiletine	69
Overall Study	COMPLETED	Nortriptyline	132
Overall Study	COMPLETED	Duloxetine	118
Overall Study	COMPLETED	Pregabalin	70
Overall Study	COMPLETED	Mexiletine	65
Overall Study	NOT COMPLETED	Nortriptyline	2
Overall Study	NOT COMPLETED	Duloxetine	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events32

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
other	Dry Mouth	Nervous system disorders	Nortriptyline	27	134
other	Dry Mouth	Nervous system disorders	Duloxetine	3	126
other	Dry Mouth	Nervous system disorders	Pregabalin	1	73
other	Dry Mouth	Nervous system disorders	Mexiletine	3	69
other	Drowsiness/Sleepiness	Nervous system disorders	Nortriptyline	16	134
other	Drowsiness/Sleepiness	Nervous system disorders	Duloxetine	7	126
other	Drowsiness/Sleepiness	Nervous system disorders	Pregabalin	8	73
other	Drowsiness/Sleepiness	Nervous system disorders	Mexiletine	3	69
other	Nausea	Ear and labyrinth disorders	Nortriptyline	3	134
other	Nausea	Ear and labyrinth disorders	Duloxetine	11	126

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nortriptyline	0	134
Total, all-cause mortality	Duloxetine	0	126
Total, all-cause mortality	Pregabalin	0	73
Total, all-cause mortality	Mexiletine	0	69
Total, other adverse events	Nortriptyline	75	134
Total, other adverse events	Duloxetine	59	126
Total, other adverse events	Pregabalin	29	73
Total, other adverse events	Mexiletine	27	69
Total, serious adverse events	Nortriptyline	0	134
Total, serious adverse events	Duloxetine	0	126

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27577191	DERIVED	PubMed
32809014	DERIVED	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 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/NCT02260388

GET https://conductscience.org/api/trials/v1/NCT02260388/results?page=2

API reference For AI assistants