Trial · NCT01794000
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
NCT01794000, Phase 3, Terminated, Eli Lilly and Company; results first posted 2016-07-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD). Trials, record NCT01794000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01794000
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
- NCT number
- NCT01794000
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 341 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Sickle Cell Disease
- Interventions
- Prasugrel, Placebo
- First posted
- 2013-02-18
- Last updated
- 2019-09-25
- Other registries' IDs
- eudract:2012-003837-41
- Results first posted
- 2016-07-27
- Limitations and caveats
- The study was stopped following Submission Database Lock, the topline information indicated that the primary and secondary efficacy endpoints were not met.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) | Randomization through 24 Months | The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below. |
| Secondary | Monthly Rate of Days With Pain | Randomization through 9 Months | Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below. |
| Secondary | Monthly Mean in Faces Pain Scale-Revised Score | Randomization through 9 Months | Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below. |
| Secondary | Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis) | Randomization through 24 Months | A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below. |
| Secondary | Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations) | Randomization through 24 Months | Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below. |
| Secondary | Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome) | Randomization through 24 Months | Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below. |
| Secondary | Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions) | Randomization through 24 Months | RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below. |
| Secondary | Monthly Rate of Days of Analgesic Use | Randomization through 9 Months | Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below. |
| Secondary | Quarterly Rate of School Absence Due to Sickle Cell Pain | Randomization through 9 Months | Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below. |
| Secondary | Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke | Randomization through 24 Months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) | Randomization through 24 Months | All randomized participants. | Number of Events per Participant-Year | NUMBER |
| SECONDARY | Monthly Rate of Days With Pain | Randomization through 9 Months | All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R. | Percentage of Days in a Month | LEAST_SQUARES_MEAN |
| SECONDARY | Monthly Mean in Faces Pain Scale-Revised Score | Randomization through 9 Months | All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis) | Randomization through 24 Months | All randomized participants. | Number of Events per Participant-Year | NUMBER |
| SECONDARY | Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations) | Randomization through 24 Months | All randomized participants. | Number of Events per Participant-Year | NUMBER |
| SECONDARY | Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome) | Randomization through 24 Months | All randomized participants. | Number of Events per Participant-Year | NUMBER |
| SECONDARY | Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions) | Randomization through 24 Months | All randomized participants. | Number of Events per Participant-Year | NUMBER |
| SECONDARY | Monthly Rate of Days of Analgesic Use | Randomization through 9 Months | All randomized participants who are 4 years or older and have baseline and at least one post-baseline monthly outcome measure in any month. Diaries were only provided to participants 4 years and older. | Percentage of Days in a Month | LEAST_SQUARES_MEAN |
| SECONDARY | Quarterly Rate of School Absence Due to Sickle Cell Pain | Randomization through 9 Months | All Randomized participants who are 4 years or older and have both baseline and at least one post-baseline quarterly outcome measure in any quarter. Diaries were only provided to participants 4 years and older. | Percentage of Days in a Quarter | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke | Randomization through 24 Months | No participants had a TIA or ischemic stroke at time of analysis. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) | Prasugrel | 2.295 | Number of Events per Participant-Year | ||
| Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) | Placebo | 2.767 | Number of Events per Participant-Year | ||
| Monthly Rate of Days With Pain | Prasugrel | 17.457 | Standard Error 1.558 | Percentage of Days in a Month | |
| Monthly Rate of Days With Pain | Placebo | 17.699 | Standard Error 1.551 | Percentage of Days in a Month | |
| Monthly Mean in Faces Pain Scale-Revised Score | Prasugrel | 0.7116 | Standard Error 0.0757 | Units on a Scale | |
| Monthly Mean in Faces Pain Scale-Revised Score | Placebo | 0.6148 | Standard Error 0.0753 | Units on a Scale | |
| Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis) | Prasugrel | 2.239 | Number of Events per Participant-Year | ||
| Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis) | Placebo | 2.720 | Number of Events per Participant-Year | ||
| Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations) | Prasugrel | 1.064 | Number of Events per Participant-Year | ||
| Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations) | Placebo | 1.126 | Number of Events per Participant-Year |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase (DBP) | STARTED | Prasugrel | 171 | |
| Double-Blind Phase (DBP) | STARTED | Placebo | 170 | |
| Double-Blind Phase (DBP) | Received at Least One Dose of Drug | Prasugrel | 170 | |
| Double-Blind Phase (DBP) | Received at Least One Dose of Drug | Placebo | 170 | |
| Double-Blind Phase (DBP) | Discontinued During Double Blind Phase | Prasugrel | 169 | |
| Double-Blind Phase (DBP) | Discontinued During Double Blind Phase | Placebo | 166 | |
| Double-Blind Phase (DBP) | COMPLETED | Prasugrel | 2 | |
| Double-Blind Phase (DBP) | COMPLETED | Placebo | 4 | |
| Double-Blind Phase (DBP) | NOT COMPLETED | Prasugrel | 169 | |
| Double-Blind Phase (DBP) | NOT COMPLETED | Placebo | 166 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events420
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 | Prasugrel - Double Blind Phase | 6 | 170 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo - Double Blind Phase | 11 | 170 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Prasugrel - Open Label Phase | 0 | 3 | 0 |
| other | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Prasugrel - Double Blind Phase | 90 | 170 | 223 |
| other | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Placebo - Double Blind Phase | 102 | 170 | 272 |
| other | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Prasugrel - Open Label Phase | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Prasugrel - Double Blind Phase | 17 | 170 | 23 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo - Double Blind Phase | 20 | 170 | 28 |
| other | Abdominal pain | Gastrointestinal disorders | Prasugrel - Open Label Phase | 0 | 3 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Prasugrel - Double Blind Phase | 3 | 170 | 3 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prasugrel - Double Blind Phase | ||
| Total, all-cause mortality | Placebo - Double Blind Phase | ||
| Total, all-cause mortality | Prasugrel - Open Label Phase | ||
| Total, other adverse events | Prasugrel - Double Blind Phase | 148 | 170 |
| Total, other adverse events | Placebo - Double Blind Phase | 154 | 170 |
| Total, other adverse events | Prasugrel - Open Label Phase | 1 | 3 |
| Total, serious adverse events | Prasugrel - Double Blind Phase | 100 | 170 |
| Total, serious adverse events | Placebo - Double Blind Phase | 106 | 170 |
| Total, serious adverse events | Prasugrel - Open Label Phase | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26644172 | DERIVED |
Source 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.
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/NCT01794000
GET https://conductscience.org/api/trials/v1/NCT01794000/results?page=2