Trial · NCT01769274
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
NCT01769274, Phase 2, Completed, Pfizer; results first posted 2019-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia. Trials, record NCT01769274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01769274
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
- NCT number
- NCT01769274
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Inherited Erythromelalgia
- Interventions
- PF-05089771, Placebo
- First posted
- 2013-01-16
- Last updated
- 2019-11-19
- Results first posted
- 2019-11-19
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Every 15 minutes from 0 to 4 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose. |
| Secondary | Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP2 to 8 hours post-dose. |
| Secondary | Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose | Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP3 to 10 hours post-dose. |
| Secondary | Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP4 to 28 hours post-dose. |
| Secondary | Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Maximum pain score in 4 hours period post-dosing is reported. |
| Secondary | Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose | From post EP2 to 8 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. Maximum pain score in period from post EP2 to 8 hours post-dose is reported. |
| Secondary | Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose | From the end of EP3 to 10 hours post dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. Maximum pain score in period from post EP3 to 10 hours post-dose is reported. |
| Secondary | Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. Maximum pain score in period from post EP4 to 28 hours post-dose is reported. |
| Secondary | Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. The duration of time that participants experienced PI-NRS score greater than 5 from the 0 hours to 4 hours post-dose. |
| Secondary | Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from in period from post EP2 to 8 hours post-dose is reported. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Every 15 minutes from 0 to 4 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Units on a scale | MEAN |
| SECONDARY | Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose | Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose | From post EP2 to 8 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose | From the end of EP3 to 10 hours post dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Minutes | MEAN |
| SECONDARY | Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Minutes | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Treatment Session 1: PF-05089771 1600 mg | 2.08 | Standard Deviation 2.20 | Units on a scale | |
| Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Treatment Session 1: Placebo | 2.73 | Standard Deviation 2.68 | Units on a scale | |
| Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Treatment Session 2: PF-05089771 1600 mg | 1.95 | Standard Deviation 2.29 | Units on a scale | |
| Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Treatment Session 2: Placebo | 2.04 | Standard Deviation 1.81 | Units on a scale | |
| Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Treatment Session 1: PF-05089771 1600 mg | 0.70 | Standard Deviation 0.64 | Units on a scale | |
| Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Treatment Session 1: Placebo | 0.61 | Standard Deviation 0.46 | Units on a scale | |
| Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Treatment Session 2: PF-05089771 1600 mg | 0.55 | Standard Deviation 0.51 | Units on a scale | |
| Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Treatment Session 2: Placebo | 1.08 | Standard Deviation 0.63 | Units on a scale | |
| Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose | Treatment Session 1: PF-05089771 1600 mg | 1.19 | Standard Deviation 1.22 | Units on a scale | |
| Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose | Treatment Session 1: Placebo | 1.55 | Standard Deviation 1.15 | Units on a scale |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A | 5 | |
| Part A | STARTED | Part B: PF-05089771 Then Placebo Then Placebo Then PF-05089771 | 0 | |
| Part A | STARTED | Part B: Placebo Then PF-05089771 Then PF-05089771 Then Placebo | 0 | |
| Part A | COMPLETED | Part A | 5 | |
| Part A | COMPLETED | Part B: PF-05089771 Then Placebo Then Placebo Then PF-05089771 | 0 | |
| Part A | COMPLETED | Part B: Placebo Then PF-05089771 Then PF-05089771 Then Placebo | 0 | |
| Part A | NOT COMPLETED | Part A | 0 | |
| Part A | NOT COMPLETED | Part B: PF-05089771 Then Placebo Then Placebo Then PF-05089771 | 0 | |
| Part A | NOT COMPLETED | Part B: Placebo Then PF-05089771 Then PF-05089771 Then Placebo | 0 | |
| Part B:Treatment Session1-Period1 | STARTED | Part A | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events100
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 | Abdominal pain | Gastrointestinal disorders | Treatment Session 1: PF-05089771 1600 mg | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment Session 1: Placebo | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment Session 2: PF-05089771 1600 mg | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment Session 2: Placebo | 1 | 5 | |
| other | Chapped lips | Gastrointestinal disorders | Treatment Session 1: PF-05089771 1600 mg | 1 | 5 | |
| other | Chapped lips | Gastrointestinal disorders | Treatment Session 1: Placebo | 0 | 5 | |
| other | Chapped lips | Gastrointestinal disorders | Treatment Session 2: PF-05089771 1600 mg | 0 | 5 | |
| other | Chapped lips | Gastrointestinal disorders | Treatment Session 2: Placebo | 0 | 5 | |
| other | Constipation | Gastrointestinal disorders | Treatment Session 1: PF-05089771 1600 mg | 1 | 5 | |
| other | Constipation | Gastrointestinal disorders | Treatment Session 1: Placebo | 0 | 5 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Session 1: PF-05089771 1600 mg | ||
| Total, all-cause mortality | Treatment Session 1: Placebo | ||
| Total, all-cause mortality | Treatment Session 2: PF-05089771 1600 mg | ||
| Total, all-cause mortality | Treatment Session 2: Placebo | ||
| Total, other adverse events | Treatment Session 1: PF-05089771 1600 mg | 5 | 5 |
| Total, other adverse events | Treatment Session 1: Placebo | 5 | 5 |
| Total, other adverse events | Treatment Session 2: PF-05089771 1600 mg | 5 | 5 |
| Total, other adverse events | Treatment Session 2: Placebo | 4 | 5 |
| Total, serious adverse events | Treatment Session 1: PF-05089771 1600 mg | 0 | 5 |
| Total, serious adverse events | Treatment Session 1: Placebo | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27099175 | 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/NCT01769274
GET https://conductscience.org/api/trials/v1/NCT01769274/registered?page=2