Trial · NCT00785577

A Study for Treatment of Pain in Patients With Diabetic Neuropathy.

NCT00785577, Phase 2, Completed, Eli Lilly and Company; results first posted 2012-05-31

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study for Treatment of Pain in Patients With Diabetic Neuropathy. Trials, record NCT00785577. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00785577

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Trial

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

Title: A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
NCT number: NCT00785577
Status: Completed
Phases: Phase 2
Enrollment: 273 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Diabetic Neuropathy, Painful
Interventions: Placebo, Pregabalin, LY545694 21 mg, LY545694 49 mg, LY545694 105 mg
First posted: 2008-11-05
Last updated: 2012-05-31
Results first posted: 2012-05-31

Source ClinicalTrials.gov

Registered outcomes26

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks	Baseline, 5 weeks	This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	Baseline, 5 weeks	This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks	Baseline, 5 weeks	This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score	Baseline through 5 weeks	This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
Secondary	Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks	Baseline, 5 weeks	Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks	Baseline, 5 weeks	BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks	Baseline, 5 weeks	CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks	Week 5	PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks	Baseline, 5 weeks	SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Secondary	Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks	Baseline, 5 weeks	ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score	Baseline through 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.	participants	NUMBER
SECONDARY	Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks	Week 5	The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks	Baseline, 5 weeks	The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group169

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks	Placebo	-2.08	Standard Error 0.22	units on a scale
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks	LY545694 21 mg	-2.22	Standard Error 0.36	units on a scale
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks	LY545694 49 mg	-2.45	Standard Error 0.32	units on a scale
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks	LY545694 105 mg	-2.42	Standard Error 0.33	units on a scale
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	Placebo	-2.31	Standard Error 0.23	units on a scale
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	Pregabalin	-2.75	Standard Error 0.33	units on a scale
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	LY545694 21 mg	-2.25	Standard Error 0.37	units on a scale
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	LY545694 49 mg	-2.54	Standard Error 0.33	units on a scale
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks	LY545694 105 mg	-2.21	Standard Error 0.34	units on a scale
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks	Placebo	-2.27	Standard Error 0.25	units on a scale

1 to 10 of 169Source ClinicalTrials.gov

See all 169 results by group

Participant flow30

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

Period	Milestone	Group	Participants
Study Period 2: Therapy Phase	STARTED	Placebo	89
Study Period 2: Therapy Phase	STARTED	Pregabalin	45
Study Period 2: Therapy Phase	STARTED	LY545694 21 mg	43
Study Period 2: Therapy Phase	STARTED	LY545694 49 mg	49
Study Period 2: Therapy Phase	STARTED	LY545694 105 mg	47
Study Period 2: Therapy Phase	COMPLETED	Placebo	78
Study Period 2: Therapy Phase	COMPLETED	Pregabalin	36
Study Period 2: Therapy Phase	COMPLETED	LY545694 21 mg	25
Study Period 2: Therapy Phase	COMPLETED	LY545694 49 mg	36
Study Period 2: Therapy Phase	COMPLETED	LY545694 105 mg	27

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events2,520

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	Leukopenia	Blood and lymphatic system disorders	Placebo	0	89	0
other	Leukopenia	Blood and lymphatic system disorders	LY545694 21 mg	0	43	0
other	Leukopenia	Blood and lymphatic system disorders	LY545694 49 mg	0	49	0
other	Leukopenia	Blood and lymphatic system disorders	LY545694 105 mg	0	47	0
other	Leukopenia	Blood and lymphatic system disorders	Pregabalin	1	45	1
other	Leukopenia	Blood and lymphatic system disorders	Placebo Washout	0	89	0
other	Leukopenia	Blood and lymphatic system disorders	LY545694 21 mg Washout	0	43	0
other	Leukopenia	Blood and lymphatic system disorders	LY545694 49 mg Washout	0	49	0
other	Leukopenia	Blood and lymphatic system disorders	LY545694 105 mg Washout	0	47	0
other	Leukopenia	Blood and lymphatic system disorders	Pregabalin Washout	0	45	0

1 to 10 of 2,520Source ClinicalTrials.gov

See all 2,520 adverse events

Adverse event totals30

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	LY545694 21 mg
Total, all-cause mortality	LY545694 49 mg
Total, all-cause mortality	LY545694 105 mg
Total, all-cause mortality	Pregabalin
Total, all-cause mortality	Placebo Washout
Total, all-cause mortality	LY545694 21 mg Washout
Total, all-cause mortality	LY545694 49 mg Washout
Total, all-cause mortality	LY545694 105 mg Washout
Total, all-cause mortality	Pregabalin Washout

1 to 10 of 30Source ClinicalTrials.gov

See all 30 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.

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