Trial · NCT00784875
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
NCT00784875, Phase 2, Completed, Eli Lilly and Company; results first posted 2012-02-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia. Trials, record NCT00784875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
- NCT number
- NCT00784875
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 643 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Primary Insomnia, Secondary Insomnia
- Interventions
- LY2624803, LY2624803, Placebo, zolpidem
- First posted
- 2008-11-04
- Last updated
- 2012-02-29
- Results first posted
- 2012-02-29
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Unwanted time awake (minutes awake \[MA\] before sleep \[between turning off the lights to first falling asleep\], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type. |
| Secondary | Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Secondary | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary) |
| Secondary | Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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 Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | number of awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group344
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | LY2624803 1 mg | 30.16 | Standard Error 5.300 | minutes | |
| Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | LY2624803 3 mg | 37.33 | Standard Error 5.186 | minutes | |
| Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | Zolpidem 5 or 10 mg | 50.63 | Standard Error 5.186 | minutes | |
| Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | Placebo | 22.79 | Standard Error 5.153 | minutes | |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | LY2624803 1 mg | Before Sleep (n= 101, 101, 101, 101) | -7.08 | Standard Error 2.524 | minutes |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | LY2624803 3 mg | Before Sleep (n= 101, 101, 101, 101) | -6.45 | Standard Error 2.444 | minutes |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Zolpidem 5 or 10 mg | Before Sleep (n= 101, 101, 101, 101) | -20.48 | Standard Error 2.440 | minutes |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Placebo | Before Sleep (n= 101, 101, 101, 101) | -1.46 | Standard Error 2.420 | minutes |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | LY2624803 1 mg | During Sleep (n= 101, 102, 101, 101) | -14.84 | Standard Error 2.881 | minutes |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | LY2624803 3 mg | During Sleep (n= 101, 102, 101, 101) | -12.95 | Standard Error 2.812 | minutes |
1 to 10 of 344Source ClinicalTrials.gov
See all 344 results by groupParticipant flow52
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period A - Baseline | STARTED | LY2624803 1 mg | 0 | |
| Period A - Baseline | STARTED | LY2624803 3 mg | 0 | |
| Period A - Baseline | STARTED | Zolpidem 5 or 10 mg | 0 | |
| Period A - Baseline | STARTED | Placebo | 643 | |
| Period A - Baseline | COMPLETED | LY2624803 1 mg | 0 | |
| Period A - Baseline | COMPLETED | LY2624803 3 mg | 0 | |
| Period A - Baseline | COMPLETED | Zolpidem 5 or 10 mg | 0 | |
| Period A - Baseline | COMPLETED | Placebo | 461 | |
| Period A - Baseline | NOT COMPLETED | LY2624803 1 mg | 0 | |
| Period A - Baseline | NOT COMPLETED | LY2624803 3 mg | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 participant flowAdverse events1,680
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 | Anaemia | Blood and lymphatic system disorders | Period B - LY2624803 1 mg | 0 | 114 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period B - LY2624803 3 mg | 0 | 113 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period B - Placebo | 0 | 117 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period B - Zolpidem 5 or 10 mg | 0 | 117 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period C - LY2624803 1 mg | 0 | 103 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period C - LY2624803 3 mg | 1 | 97 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Period C - Placebo | 0 | 98 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period C - Zolpidem 5 or 10 mg | 0 | 97 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period D - LY2624803 1 mg | 0 | 91 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Period D - LY2624803 3 mg | 1 | 89 | 1 |
1 to 10 of 1,680Source ClinicalTrials.gov
See all 1,680 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period B - LY2624803 1 mg | ||
| Total, all-cause mortality | Period B - LY2624803 3 mg | ||
| Total, all-cause mortality | Period B - Placebo | ||
| Total, all-cause mortality | Period B - Zolpidem 5 or 10 mg | ||
| Total, all-cause mortality | Period C - LY2624803 1 mg | ||
| Total, all-cause mortality | Period C - LY2624803 3 mg | ||
| Total, all-cause mortality | Period C - Placebo | ||
| Total, all-cause mortality | Period C - Zolpidem 5 or 10 mg | ||
| Total, all-cause mortality | Period D - LY2624803 1 mg | ||
| Total, all-cause mortality | Period D - LY2624803 3 mg |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
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.
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/NCT00784875
GET https://conductscience.org/api/trials/v1/NCT00784875/registered?page=2