Trial · NCT01939366

Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves

NCT01939366, Phase 2, Completed, Tris Pharma, Inc.; results first posted 2019-12-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves. Trials, record NCT01939366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01939366

On this page

Trial

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

Title: Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
NCT number: NCT01939366
Status: Completed
Phases: Phase 2
Enrollment: 699 participants, actual
Lead sponsor: Tris Pharma, Inc.
Conditions: Chronic Pain, Diabetic Neuropathies, Diabetes Mellitus
Interventions: Cebranopadol 100 µg, Cebranopadol 300 µg, Cebranopadol 600 µg, Pregabalin, Matching Placebo
First posted: 2013-09-11
Last updated: 2021-07-15
Other registries' IDs: eudract:2013-000473-68
Results first posted: 2019-12-26

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change in Average Pain Intensity.	Baseline; to End of Week 6 of the Maintenance Phase	Participants will be asked to record their pain intensity in the evening. Participants are asked to rate how much pain they had on average in the past 24 hours. The participant scores their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline average pain scores are calculated from the averages of all scores recorded during the 3 days prior to randomization. The average pain at week 6 will be the average pain scores calculated from all pain scores measured during week 6.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Average Pain Intensity.	Baseline; to End of Week 6 of the Maintenance Phase	Full Analysis Set (FAS). Mixed-effects model for repeated measures (MMRM).	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Change in Average Pain Intensity.	Cebranopadol 100 µg	-2.24	95% Confidence Interval -2.78 to -1.70	units on a scale
Change in Average Pain Intensity.	Cebranopadol 300 µg	-2.28	95% Confidence Interval -2.86 to -1.71	units on a scale
Change in Average Pain Intensity.	Cebranopadol 600 µg	-2.56	95% Confidence Interval -3.20 to -1.91	units on a scale
Change in Average Pain Intensity.	Pregabalin	-2.79	95% Confidence Interval -3.33 to -2.26	units on a scale
Change in Average Pain Intensity.	Matching Placebo	-1.55	95% Confidence Interval -2.10 to -1.00	units on a scale

Source ClinicalTrials.gov

Participant flow35

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cebranopadol 100 µg	66
Overall Study	STARTED	Cebranopadol 300 µg	64
Overall Study	STARTED	Cebranopadol 600 µg	65
Overall Study	STARTED	Pregabalin	68
Overall Study	STARTED	Matching Placebo	66
Overall Study	Allocated Set Excl. Non-compliant Sites	Cebranopadol 100 µg	64
Overall Study	Allocated Set Excl. Non-compliant Sites	Cebranopadol 300 µg	61
Overall Study	Allocated Set Excl. Non-compliant Sites	Cebranopadol 600 µg	63
Overall Study	Allocated Set Excl. Non-compliant Sites	Pregabalin	65
Overall Study	Allocated Set Excl. Non-compliant Sites	Matching Placebo	63

1 to 10 of 35Source ClinicalTrials.gov

See all 35 participant flow

Adverse events135

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	Abdominal pain upper	Gastrointestinal disorders	Cebranopadol 100 µg	0	64
other	Abdominal pain upper	Gastrointestinal disorders	Cebranopadol 300 µg	6	61
other	Abdominal pain upper	Gastrointestinal disorders	Cebranopadol 600 µg	0	62
other	Abdominal pain upper	Gastrointestinal disorders	Pregabalin	0	65
other	Abdominal pain upper	Gastrointestinal disorders	Matching Placebo	2	62
other	Constipation	Gastrointestinal disorders	Cebranopadol 100 µg	3	64
other	Constipation	Gastrointestinal disorders	Cebranopadol 300 µg	6	61
other	Constipation	Gastrointestinal disorders	Cebranopadol 600 µg	7	62
other	Constipation	Gastrointestinal disorders	Pregabalin	6	65
other	Constipation	Gastrointestinal disorders	Matching Placebo	2	62

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cebranopadol 100 µg	0	64
Total, all-cause mortality	Cebranopadol 300 µg	0	61
Total, all-cause mortality	Cebranopadol 600 µg	0	62
Total, all-cause mortality	Pregabalin	0	65
Total, all-cause mortality	Matching Placebo	0	62
Total, other adverse events	Cebranopadol 100 µg	47	64
Total, other adverse events	Cebranopadol 300 µg	50	61
Total, other adverse events	Cebranopadol 600 µg	53	62
Total, other adverse events	Pregabalin	49	65
Total, other adverse events	Matching Placebo	43	62

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/NCT01939366

GET https://conductscience.org/api/trials/v1/NCT01939366/flow?page=2

API reference For AI assistants