Trial · NCT03831880
Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
NCT03831880, Phase 3, Completed, Pfizer; results first posted 2021-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD. Trials, record NCT03831880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03831880
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
- NCT number
- NCT03831880
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 87 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Growth Hormone Deficiency
- Interventions
- Genotropin, somatrogon
- First posted
- 2019-02-06
- Last updated
- 2021-10-14
- Other registries' IDs
- eudract:2018-000918-38
- Results first posted
- 2021-10-14
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire | Baseline | Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome). |
| Primary | Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire | Week 12 | Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome). |
| Primary | Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire | Week 24 | Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome). |
| Primary | Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome). |
| Secondary | Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Baseline, Week 12, Week 24 | Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome. |
| Secondary | Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked 5 questions from Section I of the IPAQ PRO tool related to pen ease of use and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to pen ease of use was sum of all 5 questions; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome. |
| Secondary | Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Baseline, Week 12, Week 24 | Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to ease of the injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome. |
| Secondary | Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 5-point scale: 1= very easy, 2= somewhat easy, 3= neither easy nor difficult, 4= somewhat difficult, 5= very difficult. The total score related to ease of the injection schedule ranged from 1 to 5; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome. |
| Secondary | Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Baseline, Week 12, Week 24 | Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 7-point scale: 1=extremely convenient to 7=extremely inconvenient. The total score related to convenience of injection schedule ranged from 1 to 7; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome. |
| Secondary | Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | Participants were assessed for their treatment experience using DCOA 1 questionnaire completed by participant/caregiver dyads. Participants were asked a question from Section I of the IPAQ PRO tool related to ease of injection schedule and used a 7-point scale: 1=extremely convenient to 7=extremely inconvenient. The total score related to convenience of injection schedule ranged from 1 to 7; scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant a better outcome. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire | Baseline | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire | Week 12 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire | Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Baseline, Week 12, Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points. | units on a scale | MEAN |
| SECONDARY | Total Score Related to Pen Ease of Use by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Total Score Related to Ease of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Baseline, Week 12, Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points. | units on a scale | MEAN |
| SECONDARY | Total Score Related to Ease of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Total Score Related to Convenience of the Injection Schedule Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Baseline, Week 12, Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here 'number analyzed' signifies participants evaluable for each specified time points. | units on a scale | MEAN |
| SECONDARY | Total Score Related to Convenience of the Injection Schedule by Treatment in Overall Study, Using DCOA 1 Questionnaire | Baseline up to Week 24 | The full analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group298
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire | Daily Genotropin Then Weekly Somatrogon | 29.5 | Standard Deviation 18.0 | units on a scale | |
| Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire | Weekly Somatrogon Then Daily Genotropin | 27.1 | Standard Deviation 19.8 | units on a scale | |
| Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire | Daily Genotropin Then Weekly Somatrogon | 25.2 | Standard Deviation 17.3 | units on a scale | |
| Total Score Related to Overall Life Interference Assessed at Week 12, Using DCOA 1 Questionnaire | Weekly Somatrogon Then Daily Genotropin | 7.1 | Standard Deviation 7.8 | units on a scale | |
| Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire | Daily Genotropin Then Weekly Somatrogon | 9.5 | Standard Deviation 13.3 | units on a scale | |
| Total Score Related to Overall Life Interference Assessed at Week 24, Using DCOA 1 Questionnaire | Weekly Somatrogon Then Daily Genotropin | 23.0 | Standard Deviation 22.6 | units on a scale | |
| Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire | Genotropin | 24.13 | 95% Confidence Interval 20.61 to 27.65 | units on a scale | |
| Total Score Related to Overall Life Interference by Treatment in Overall Study, Using DCOA 1 Questionnaire | Somatrogon | 8.63 | 95% Confidence Interval 5.05 to 12.22 | units on a scale | |
| Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Daily Genotropin Then Weekly Somatrogon | Baseline | 10.6 | Standard Deviation 11.3 | units on a scale |
| Total Score Related to Pen Ease of Use Assessed at Baseline, Week 12 and Week 24, Using DCOA 1 Questionnaire | Weekly Somatrogon Then Daily Genotropin | Baseline | 11.6 | Standard Deviation 12.8 | units on a scale |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (12 Weeks) | STARTED | Daily Genotropin Then Weekly Somatrogon | 43 | |
| Period 1 (12 Weeks) | STARTED | Weekly Somatrogon Then Daily Genotropin | 44 | |
| Period 1 (12 Weeks) | COMPLETED | Daily Genotropin Then Weekly Somatrogon | 43 | |
| Period 1 (12 Weeks) | COMPLETED | Weekly Somatrogon Then Daily Genotropin | 43 | |
| Period 1 (12 Weeks) | NOT COMPLETED | Daily Genotropin Then Weekly Somatrogon | 0 | |
| Period 1 (12 Weeks) | NOT COMPLETED | Weekly Somatrogon Then Daily Genotropin | 1 | |
| Period 2 (12 Weeks) | STARTED | Daily Genotropin Then Weekly Somatrogon | 43 | |
| Period 2 (12 Weeks) | STARTED | Weekly Somatrogon Then Daily Genotropin | 43 | |
| Period 2 (12 Weeks) | COMPLETED | Daily Genotropin Then Weekly Somatrogon | 43 | |
| Period 2 (12 Weeks) | COMPLETED | Weekly Somatrogon Then Daily Genotropin | 42 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events134
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 | Ear pain | Ear and labyrinth disorders | Genotropin | 0 | 86 | |
| other | Ear pain | Ear and labyrinth disorders | Somatrogon | 1 | 87 | |
| other | Hyperacusis | Ear and labyrinth disorders | Genotropin | 0 | 86 | |
| other | Hyperacusis | Ear and labyrinth disorders | Somatrogon | 1 | 87 | |
| other | Adrenocortical insufficiency acute | Endocrine disorders | Genotropin | 0 | 86 | |
| other | Adrenocortical insufficiency acute | Endocrine disorders | Somatrogon | 1 | 87 | |
| other | Eye pruritus | Eye disorders | Genotropin | 1 | 86 | |
| other | Eye pruritus | Eye disorders | Somatrogon | 0 | 87 | |
| other | Vision blurred | Eye disorders | Genotropin | 1 | 86 | |
| other | Vision blurred | Eye disorders | Somatrogon | 0 | 87 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genotropin | 0 | 86 |
| Total, all-cause mortality | Somatrogon | 0 | 87 |
| Total, other adverse events | Genotropin | 38 | 86 |
| Total, other adverse events | Somatrogon | 47 | 87 |
| Total, serious adverse events | Genotropin | 0 | 86 |
| Total, serious adverse events | Somatrogon | 0 | 87 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Genotropin vs Somatrogon: deaths from any cause | Trial comparisons |
| Genotropin vs Somatrogon: Number of Participants With Discontinuation Due to Adverse Events (AEs) | Trial comparisons |
| Genotropin vs Somatrogon: serious adverse events | Trial comparisons |
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/NCT03831880
GET https://conductscience.org/api/trials/v1/NCT03831880/registered?page=2