Trial · NCT00345800
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
NCT00345800, Phase 1, Completed, UCB Pharma SA; results first posted 2022-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes. Trials, record NCT00345800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345800
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
- NCT number
- NCT00345800
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 25 participants, actual
- Lead sponsor
- UCB Pharma SA
- Conditions
- Narcolepsy With Cataplexy
- Interventions
- Sodium Oxybate (Xyrem)
- First posted
- 2006-06-29
- Last updated
- 2022-04-08
- Other registries' IDs
- eudract:2005-004417-15
- Results first posted
- 2022-04-08
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2. |
| Primary | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) | After 1 month of treatment (Visit 3) | An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3. |
| Primary | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) | After 3 months of treatment (Visit 4) | An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4. |
| Secondary | The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH. |
| Secondary | The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3 | Visit 3 (approximately 1 month) | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH. |
| Secondary | The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4 | Visit 4 (approximately 3 months) | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH. |
| Secondary | Cortisol Measured at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol. |
| Secondary | Cortisol Measured at Visit 3 | Visit 3 (approximately 1 month) | Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol. |
| Secondary | Cortisol Measured at Visit 4 | Visit 4 (approximately 3 months) | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol. |
| Secondary | The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ng/mL | MEAN |
| PRIMARY | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) | After 1 month of treatment (Visit 3) | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ng/mL | MEAN |
| PRIMARY | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) | After 3 months of treatment (Visit 4) | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ng/mL | MEAN |
| SECONDARY | The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ng/mL | MEAN |
| SECONDARY | The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3 | Visit 3 (approximately 1 month) | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ng/mL | MEAN |
| SECONDARY | The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4 | Visit 4 (approximately 3 months) | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ng/mL | MEAN |
| SECONDARY | Cortisol Measured at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ug/L | MEAN |
| SECONDARY | Cortisol Measured at Visit 3 | Visit 3 (approximately 1 month) | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ug/L | MEAN |
| SECONDARY | Cortisol Measured at Visit 4 | Visit 4 (approximately 3 months) | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | ug/L | MEAN |
| SECONDARY | The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2) | Baseline (Visit 2) - approximately 1 day | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | pg/mL | MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) | Sodium Oxybate | 207.4 | Standard Deviation 86.5 | ng/mL | |
| The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) | Sodium Oxybate | 200.4 | Standard Deviation 77.7 | ng/mL | |
| The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) | Sodium Oxybate | 210.2 | Standard Deviation 90.3 | ng/mL | |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | Bed time | 1.821 | Standard Deviation 4.844 | ng/mL |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | 1h | 1.225 | Standard Deviation 2.895 | ng/mL |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | 2h | 1.408 | Standard Deviation 1.656 | ng/mL |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | 4h | 1.236 | Standard Deviation 1.904 | ng/mL |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | 8h | 0.576 | Standard Deviation 0.632 | ng/mL |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | 12h | 0.293 | Standard Deviation 0.310 | ng/mL |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Sodium Oxybate | 16h | 0.309 | Standard Deviation 0.282 | ng/mL |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Oxybate | 25 | |
| Overall Study | COMPLETED | Sodium Oxybate | 25 | |
| Overall Study | NOT COMPLETED | Sodium Oxybate | 0 |
Source ClinicalTrials.gov
Adverse events11
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 | Nausea | Gastrointestinal disorders | Sodium Oxybate | 5 | 25 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Sodium Oxybate | 3 | 25 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Sodium Oxybate | 2 | 25 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Sodium Oxybate | 2 | 25 | 2 |
| other | Osteoarthritis | Musculoskeletal and connective tissue disorders | Sodium Oxybate | 2 | 25 | 4 |
| other | Headache | Nervous system disorders | Sodium Oxybate | 6 | 25 | 8 |
| other | Dizziness | Nervous system disorders | Sodium Oxybate | 2 | 25 | 2 |
| other | Anxiety | Psychiatric disorders | Sodium Oxybate | 2 | 25 | 6 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sodium Oxybate | 2 | 25 | 3 |
| other | Hyperhidrosis | Skin and subcutaneous tissue disorders | Sodium Oxybate | 2 | 25 | 2 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Oxybate | 0 | 25 |
| Total, other adverse events | Sodium Oxybate | 15 | 25 |
| Total, serious adverse events | Sodium Oxybate | 1 | 25 |
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/NCT00345800
GET https://conductscience.org/api/trials/v1/NCT00345800/registered?page=2