Trial · NCT00774930
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
NCT00774930, Phase 3, Completed, Ipsen; results first posted 2016-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome. Trials, record NCT00774930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00774930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
- NCT number
- NCT00774930
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 115 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Carcinoid Syndrome
- Interventions
- Lanreotide, Placebo
- First posted
- 2008-10-17
- Last updated
- 2022-10-14
- Other registries' IDs
- eudract:2010-019066-92
- Results first posted
- 2016-02-09
- Limitations and caveats
- None specified.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Days With Subcutaneous Octreotide as Rescue Medication | 16-week DB phase | Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records. |
| Secondary | Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records. | 16-week DB phase | |
| Secondary | Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records. | 16-week DB phase | |
| Secondary | Percentage of Days of Use of Other Rescue Medication | 16-week DB phase | Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium). |
| Secondary | Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study | 16-week DB phase | Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection. |
| Secondary | Changes From Baseline in "Global Health Status/Quality of Life (QoL)" Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30) | Baseline and Week 12 of DB phase | Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment. Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n. For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS. |
| Secondary | Changes From Baseline in "Gastrointestinal (G.I). Symptoms" Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21] | Baseline and Week 12 of DB phase | Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment. The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n. For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS. |
| Secondary | Changes From Baseline in QoL in "Endocrine Symptoms" Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires) | Baseline and Week 12 of DB phase | Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment. The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n. For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS. |
| Secondary | Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA]) | Baseline and Week 12 of DB phase | Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment. |
| Secondary | Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA]) | Baseline and Week 12 of DB phase | Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Days With Subcutaneous Octreotide as Rescue Medication | 16-week DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records. | 16-week DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group. | Number of events per day | MEAN |
| SECONDARY | Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records. | 16-week DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group. | Number of events per day | MEAN |
| SECONDARY | Percentage of Days of Use of Other Rescue Medication | 16-week DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group. | Percentage of days | MEAN |
| SECONDARY | Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study | 16-week DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group. | Percentage of subjects | NUMBER |
| SECONDARY | Changes From Baseline in Global Health Status/Quality of Life (QoL) Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30) | Baseline and Week 12 of DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis. | Units on a scale | MEAN |
| SECONDARY | Changes From Baseline in Gastrointestinal (G.I). Symptoms Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21] | Baseline and Week 12 of DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis. | Units on a scale | MEAN |
| SECONDARY | Changes From Baseline in QoL in Endocrine Symptoms Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires) | Baseline and Week 12 of DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis. | Units on a scale | MEAN |
| SECONDARY | Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA]) | Baseline and Week 12 of DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis. | μg/L | MEAN |
| SECONDARY | Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA]) | Baseline and Week 12 of DB phase | ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis. | μmol/day | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Days With Subcutaneous Octreotide as Rescue Medication | Lanreotide Autogel (Somatuline Depot) 120 mg | 33.72 | 95% Confidence Interval 25.02 to 42.42 | Percentage of days | |
| Percentage of Days With Subcutaneous Octreotide as Rescue Medication | Placebo | 48.49 | 95% Confidence Interval 39.57 to 57.40 | Percentage of days | |
| Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records. | Lanreotide Autogel (Somatuline Depot) 120 mg | 1.56 | Standard Deviation 1.83 | Number of events per day | |
| Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records. | Placebo | 1.35 | Standard Deviation 1.45 | Number of events per day | |
| Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records. | Lanreotide Autogel (Somatuline Depot) 120 mg | 0.92 | Standard Deviation 1.45 | Number of events per day | |
| Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records. | Placebo | 1.75 | Standard Deviation 2.26 | Number of events per day | |
| Percentage of Days of Use of Other Rescue Medication | Lanreotide Autogel (Somatuline Depot) 120 mg | 8.86 | Standard Deviation 19.34 | Percentage of days | |
| Percentage of Days of Use of Other Rescue Medication | Placebo | 6.25 | Standard Deviation 17.48 | Percentage of days | |
| Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study | Lanreotide Autogel (Somatuline Depot) 120 mg | 18.6 | Percentage of subjects | ||
| Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study | Placebo | 21.4 | Percentage of subjects |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Phase | STARTED | Lanreotide Autogel (Somatuline Depot) 120 mg | 59 | |
| DB Phase | STARTED | Placebo | 56 | |
| DB Phase | COMPLETED | Lanreotide Autogel (Somatuline Depot) 120 mg | 45 | |
| DB Phase | COMPLETED | Placebo | 34 | |
| DB Phase | NOT COMPLETED | Lanreotide Autogel (Somatuline Depot) 120 mg | 14 | |
| DB Phase | NOT COMPLETED | Placebo | 22 | |
| IOL Phase | STARTED | Lanreotide Autogel (Somatuline Depot) 120 mg | 56 | |
| IOL Phase | STARTED | Placebo | 46 | |
| IOL Phase | COMPLETED | Lanreotide Autogel (Somatuline Depot) 120 mg | 43 | |
| IOL Phase | COMPLETED | Placebo | 37 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events340
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 | Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) | 5 | 58 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo (DB Phase) | 5 | 57 | 5 |
| other | Nausea | Gastrointestinal disorders | Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) | 8 | 101 | 9 |
| other | Nausea | Gastrointestinal disorders | Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase) | 4 | 57 | 5 |
| other | Vomiting | Gastrointestinal disorders | Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) | 4 | 58 | 6 |
| other | Vomiting | Gastrointestinal disorders | Placebo (DB Phase) | 2 | 57 | 2 |
| other | Vomiting | Gastrointestinal disorders | Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) | 6 | 101 | 6 |
| other | Vomiting | Gastrointestinal disorders | Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase) | 5 | 57 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) | 5 | 58 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (DB Phase) | 7 | 57 | 7 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) | ||
| Total, all-cause mortality | Placebo (DB Phase) | ||
| Total, all-cause mortality | Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) | ||
| Total, all-cause mortality | Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase) | ||
| Total, other adverse events | Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) | 31 | 58 |
| Total, other adverse events | Placebo (DB Phase) | 34 | 57 |
| Total, other adverse events | Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) | 71 | 101 |
| Total, other adverse events | Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase) | 46 | 57 |
| Total, serious adverse events | Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) | 2 | 58 |
| Total, serious adverse events | Placebo (DB Phase) | 5 | 57 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00774930
GET https://conductscience.org/api/trials/v1/NCT00774930/events?page=2