Trial · NCT00853047
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Up to 4 Weeks Core Phase | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1. |
| Primary | Number of Participants With Any TEAE in the Open-Label Extension Phase | Up to 180 weeks in the open-label extension phase | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment. |
| Secondary | Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day | Baseline to Week 4 | Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Weekly Mean Stool Form | Baseline to Week 4 | Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate | Baseline to Week 4 | Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Number of Cutaneous Flushing Episodes | Baseline to Week 4 | Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Severity of Abdominal Pain or Discomfort | Baseline to Week 4 | Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) | Baseline to Week 4 | u5-HIAA is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Chromogranin A | Baseline to Week 4 | Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement. |
| Secondary | Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome | Week 4 | Participants were asked to answer the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?". The number of participants who answered Yes are reported. |
| Secondary | Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day | Baseline to Week 4 | Participants recorded details (location and frequency of injection) of subcutaneous injections of rescue, short-acting octreotide, if taken, in the daily diary. A negative change from Baseline indicates improvement. |
| Secondary | Time to First Rescue, Short-acting Octreotide | Baseline to Week 4 | Time to the first subcutaneous injections of rescue, short-acting octreotide was determined from the participant's daily diary. |
| Secondary | Number of Participants Experiencing Complete Response at Week 4 | Baseline to Week 4 | Complete Response to treatment was defined as one of the following: 1. Less than 4 bowel movements per day; or 2. A decrease in daily bowel movements that is ≥ 50% from baseline; or 3. A positive response to the global assessment question ("In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain or discomfort?") for each of the last 2 weeks of the Treatment Period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00853047/registered