Trial · NCT05405257
Oxytocin for Hypermobile Ehlers-Danlos Syndrome
NCT05405257, Phase 1, Phase 2, Terminated, Baylor College of Medicine; results first posted 2025-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oxytocin for Hypermobile Ehlers-Danlos Syndrome. Trials, record NCT05405257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05405257
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxytocin for Hypermobile Ehlers-Danlos Syndrome
- NCT number
- NCT05405257
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Pain Assessment
- Interventions
- Oxytocin, Placebo
- First posted
- 2022-06-06
- Last updated
- 2025-08-28
- Results first posted
- 2025-08-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Participant's Subjective Reported Chronic Pain | Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated. | Study evaluated maximum pain level by using the Brief Pain Inventory (BPI). Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome). |
| Primary | Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 1 of pre-infusion period / 6 days prior to the infusion) and once after treatment with placebo OR oxytocin (day 1 of post-infusion period / 1 day after the infusion) | Change in the individual's subjective reported pain following treatment with placebo compared to the change in reported pain following treatment with oxytocin as assessed by McGill Pain Questionnaire. The McGill questionnaire is a self-report measure that explores both the quality and intensity of pain. Minimum score: is 0 (no pain) and maximum score is 78 (severe pain). Higher score indicates higher level of pain (worse outcome) |
| Primary | Change in Participant's Subjective Reported Pain | Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated. | Study evaluated maximum pain level by using the Numerical pain rating scale. Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome). |
| Secondary | Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion) | Change in the individual's anxiety following treatment with placebo compared to the change in reported anxiety following treatment with oxytocin as assessed by Hospital anxiety and depression scale The Hospital anxiety and depression scale is a self-report measure to evaluate anxiety and depression. Minimum score is 0 and maximum score is 21. Higher score indicates higher level of anxiety (worse outcome) 0-7: Normal or no anxiety/depression. 8-10: Mild anxiety/depression. 11-14: Moderate anxiety/depression. 15-21: Severe anxiety/depression. |
| Secondary | Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion) | Change in the individual's depression following treatment with placebo compared to the change in reported depression following treatment with oxytocin as assessed by Hospital anxiety and depression scale The Hospital anxiety and depression scale is a self-report measure to evaluate anxiety and depression. Minimum score is 0, maximum score is 21. Higher score indicates higher level of depression (worse outcome) 0-7: Normal or no anxiety/depression. 8-10: Mild anxiety/depression. 11-14: Moderate anxiety/depression. 15-21: Severe anxiety/depression. |
| Secondary | Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion) | Change in the individual's anxiety following treatment with placebo compared to the change in reported anxiety following treatment with oxytocin as assessed by the "state" part of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. Minimum score is 20 to maximum score is 80. Higher score indicates higher level of anxiety (worse outcome) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Participant's Subjective Reported Chronic Pain | Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated. | Only one patient completed the sequence | score on a scale | MEAN |
| PRIMARY | Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 1 of pre-infusion period / 6 days prior to the infusion) and once after treatment with placebo OR oxytocin (day 1 of post-infusion period / 1 day after the infusion) | One patient who completed the entire sequence | score on a scale | NUMBER |
| PRIMARY | Change in Participant's Subjective Reported Pain | Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated. | Only one patient completed the sequence | score on a scale | MEAN |
| SECONDARY | Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion) | One patient who completed the entire sequence | score on a scale | NUMBER |
| SECONDARY | Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion) | One patient who completed the entire sequence | score on a scale | NUMBER |
| SECONDARY | Change Between Pre and Post Treatment Anxiety Scores Using the State Part of the State-Trait Anxiety Inventory (STAI) Questionnaire. | Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion) | One patient who completed the entire sequence | score on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Participant's Subjective Reported Chronic Pain | Placebo-Oxytocine Sequence | Mean pain levels pre-placebo (mean of values documented on days 1,3,5 of pre treatment period) | 5.3 | Standard Deviation 1.15 | score on a scale |
| Change in Participant's Subjective Reported Chronic Pain | Placebo-Oxytocine Sequence | Mean pain levels post placebo (mean of values documented on days 1,3,5 of post treatment period) | 2 | Standard Deviation 1 | score on a scale |
| Change in Participant's Subjective Reported Chronic Pain | Placebo-Oxytocine Sequence | Mean pain levels pre-OXT (mean of values documented on days 1,3,5 of pre treatment period) | 4.3 | Standard Deviation 0.58 | score on a scale |
| Change in Participant's Subjective Reported Chronic Pain | Placebo-Oxytocine Sequence | Mean pain levels post OXT (mean of values documented on days 1,3,5 of post treatment period) | 6.7 | Standard Deviation 2.5 | score on a scale |
| Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. | Placebo-Oxytocin Sequence | Pain score pre-placebo (value documented on day 1 of pre-infusion period) | 27 | score on a scale | |
| Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. | Placebo-Oxytocin Sequence | Pain score post placebo (value documented on day 1 of post-infusion period) | 13 | score on a scale | |
| Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. | Placebo-Oxytocin Sequence | Pain score pre-OXT (value documented on day 1 of pre-infusion period) | 31 | score on a scale | |
| Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. | Placebo-Oxytocin Sequence | Pain score post OXT (value documented on day 1 of post-infusion period) | 44 | score on a scale | |
| Change in Participant's Subjective Reported Pain | Placebo-Oxytocine Sequence | Mean pain levels pre-placebo (mean of values documented on days 1,3,5 of pre treatment period) | 3.3 | Standard Deviation 1.5 | score on a scale |
| Change in Participant's Subjective Reported Pain | Placebo-Oxytocine Sequence | Mean pain levels post placebo (mean of values documented on days 1,3,5 of post treatment period) | 1.3 | Standard Deviation 1.5 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo First Then Oxytocin | 2 | |
| Overall Study | COMPLETED | Placebo First Then Oxytocin | 1 | |
| Overall Study | NOT COMPLETED | Placebo First Then Oxytocin | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sequence Placebo-oxytocin | 0 | 2 |
| Total, other adverse events | Sequence Placebo-oxytocin | 0 | 2 |
| Total, serious adverse events | Sequence Placebo-oxytocin | 0 | 2 |
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 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/NCT05405257
GET https://conductscience.org/api/trials/v1/NCT05405257/results?page=2