Trial · NCT00963040
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
NCT00963040, Not applicable, Completed, MedVadis Research Corporation; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache. Trials, record NCT00963040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00963040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
- NCT number
- NCT00963040
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 60 participants, actual
- Lead sponsor
- MedVadis Research Corporation
- Conditions
- Chronic Daily Headache
- Interventions
- Syntocinon, Sterile water, Syntocinon, Sterile water
- First posted
- 2009-08-20
- Last updated
- 2023-06-15
- Results first posted
- 2023-06-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Headache Intensity | 2 hours after administration of study medication | Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale) |
| Secondary | Reduction in Headache Intensity | ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale) |
| Secondary | Average Headache Intensity | ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible). |
| Secondary | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as nausea, vomiting, photophobia, and phonophobia |
| Secondary | Intake of Rescue Medication | Up to 24 hours after intervention administration | Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration. |
| Secondary | Participant Satisfaction | Up to 24 hours after intervention administration | Participants rated their satisfaction with treatment on a 4-point scale as "Excellent", "Good", "Moderate", or "Poor". Number (percentage) of participants who reported each rating. |
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 | Reduction in Headache Intensity | 2 hours after administration of study medication | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Reduction in Headache Intensity | ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Average Headache Intensity | ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol | score on a scale | MEAN |
| SECONDARY | Presence of Nausea, Vomiting, Photophobia, and Phonophobia | ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication | Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intake of Rescue Medication | Up to 24 hours after intervention administration | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participant Satisfaction | Up to 24 hours after intervention administration | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Headache Intensity | Syntocinon® (Oxytocin) TI-004 Protocol | 6 | Participants | ||
| Reduction in Headache Intensity | Placebo TI-004 Protocol | 4 | Participants | ||
| Reduction in Headache Intensity | Syntocinon® (Oxytocin) TI-005 Protocol | 1 | Participants | ||
| Reduction in Headache Intensity | Placebo TI-005 Protocol | 3 | Participants | ||
| Reduction in Headache Intensity | Syntocinon® (Oxytocin) TI-004 Protocol | 0.5 hours after administration | 0 | Participants | |
| Reduction in Headache Intensity | Placebo TI-004 Protocol | 0.5 hours after administration | 1 | Participants | |
| Reduction in Headache Intensity | Syntocinon® (Oxytocin) TI-005 Protocol | 0.5 hours after administration | 0 | Participants | |
| Reduction in Headache Intensity | Placebo TI-005 Protocol | 0.5 hours after administration | 0 | Participants | |
| Reduction in Headache Intensity | Syntocinon® (Oxytocin) TI-004 Protocol | 1 hour after administration | 3 | Participants | |
| Reduction in Headache Intensity | Placebo TI-004 Protocol | 1 hour after administration | 1 | Participants |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| TI-004 Protocol | STARTED | Syntocinon® (Oxytocin) TI-004 Protocol | 22 | |
| TI-004 Protocol | STARTED | Placebo TI-004 Protocol | 18 | |
| TI-004 Protocol | STARTED | Syntocinon® (Oxytocin) TI-005 Protocol | 0 | |
| TI-004 Protocol | STARTED | Placebo TI-005 Protocol | 0 | |
| TI-004 Protocol | COMPLETED | Syntocinon® (Oxytocin) TI-004 Protocol | 22 | |
| TI-004 Protocol | COMPLETED | Placebo TI-004 Protocol | 18 | |
| TI-004 Protocol | COMPLETED | Syntocinon® (Oxytocin) TI-005 Protocol | 0 | |
| TI-004 Protocol | COMPLETED | Placebo TI-005 Protocol | 0 | |
| TI-004 Protocol | NOT COMPLETED | Syntocinon® (Oxytocin) TI-004 Protocol | 0 | |
| TI-004 Protocol | NOT COMPLETED | Placebo TI-004 Protocol | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events64
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 | Conjunctivitis | Eye disorders | Syntocinon® (Oxytocin) TI-004 Protocol | 1 | 22 | |
| other | Conjunctivitis | Eye disorders | Sterile Water TI-004 Protocol | 0 | 18 | |
| other | Conjunctivitis | Eye disorders | Syntocinon® (Oxytocin) TI-005 Protocol | 0 | 12 | |
| other | Conjunctivitis | Eye disorders | Sterile Water TI-005 Protocol | 0 | 8 | |
| other | Dry mouth | Gastrointestinal disorders | Syntocinon® (Oxytocin) TI-004 Protocol | 2 | 22 | |
| other | Dry mouth | Gastrointestinal disorders | Sterile Water TI-004 Protocol | 0 | 18 | |
| other | Dry mouth | Gastrointestinal disorders | Syntocinon® (Oxytocin) TI-005 Protocol | 0 | 12 | |
| other | Dry mouth | Gastrointestinal disorders | Sterile Water TI-005 Protocol | 0 | 8 | |
| other | Nausea | Gastrointestinal disorders | Syntocinon® (Oxytocin) TI-004 Protocol | 1 | 22 | |
| other | Nausea | Gastrointestinal disorders | Sterile Water TI-004 Protocol | 1 | 18 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Syntocinon® (Oxytocin) TI-004 Protocol | 0 | 22 |
| Total, all-cause mortality | Sterile Water TI-004 Protocol | 0 | 18 |
| Total, all-cause mortality | Syntocinon® (Oxytocin) TI-005 Protocol | 0 | 12 |
| Total, all-cause mortality | Sterile Water TI-005 Protocol | 0 | 8 |
| Total, other adverse events | Syntocinon® (Oxytocin) TI-004 Protocol | 8 | 22 |
| Total, other adverse events | Sterile Water TI-004 Protocol | 3 | 18 |
| Total, other adverse events | Syntocinon® (Oxytocin) TI-005 Protocol | 2 | 12 |
| Total, other adverse events | Sterile Water TI-005 Protocol | 1 | 8 |
| Total, serious adverse events | Syntocinon® (Oxytocin) TI-004 Protocol | 0 | 22 |
| Total, serious adverse events | Sterile Water TI-004 Protocol | 0 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00963040
GET https://conductscience.org/api/trials/v1/NCT00963040/results?page=2