Trial · NCT00690898
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
NCT00690898, Phase 3, Completed, Ipsen; results first posted 2013-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma. Trials, record NCT00690898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00690898
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
- NCT number
- NCT00690898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Acromegaly
- Interventions
- Lanreotide autogel 120 mg
- First posted
- 2008-06-05
- Last updated
- 2022-10-14
- Other registries' IDs
- eudract:2007-000155-34
- Results first posted
- 2013-12-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5) | Week 1 and Week 48 | A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant. |
| Secondary | Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4). | Baseline (week 1) to week 12 and week 24 | |
| Secondary | Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels | Week 12, 24, and 48 | |
| Secondary | Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels. | Week 12, 24, and 48 | |
| Secondary | Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels | Week 12, 24 and 48 | |
| Secondary | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline | Week 12, 24 and 48 | The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged. |
| Secondary | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline | Week 12, 24 and 48 | The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged. |
| Secondary | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline | Week 12, 24 and 48 | The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged. |
| Secondary | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline | Week 12, 24 and 48 | The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged. |
| Secondary | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline | Week 12, 24 and 48 | The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5) | Week 1 and Week 48 | Analysis based on intent-to-treat (ITT) population comprised of 89 patients. | percentage of subjects | NUMBER |
| SECONDARY | Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4). | Baseline (week 1) to week 12 and week 24 | Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value. | participants | NUMBER |
| SECONDARY | Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels | Week 12, 24, and 48 | Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population. | percentage change | MEAN |
| SECONDARY | Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels. | Week 12, 24, and 48 | Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value. | percentage change | MEAN |
| SECONDARY | Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels | Week 12, 24 and 48 | Analysis based on the number (n) of subjects with baseline level between 20 ng/ml and 100 ng/ml in the ITT population with a valid value. | mcg/L | MEAN |
| SECONDARY | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline | Week 12, 24 and 48 | Analysis based on the number (n) of subjects in the ITT population with a valid value. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline | Week 12, 24 and 48 | Analysis based on the number (n) of subjects in the ITT population with a valid value. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline | Week 12, 24 and 48 | Analysis based on the number (n) of subjects in the ITT population with a valid value. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline | Week 12, 24 and 48 | Analysis based on the number (n) of subjects in the ITT population with a valid value. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline | Week 12, 24 and 48 | Analysis based on the number (n) of subjects in the ITT population with a valid value. | percentage of subjects | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5) | Lanreotide Autogel 120 mg | Greater than or equal to 20% | 62.9 | 95% Confidence Interval 52.0 to 72.9 | percentage of subjects |
| Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5) | Lanreotide Autogel 120 mg | Less than 20% | 37.1 | 95% Confidence Interval 27.1 to 48.0 | percentage of subjects |
| Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4). | Lanreotide Autogel 120 mg | Greater than or equal to 20% at week 12 (n=85) | 46 | 44.7 to 67.3 | participants |
| Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4). | Lanreotide Autogel 120 mg | Less than 20% at week 12 (n=85) | 39 | 43.0 to 65.0 | participants |
| Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4). | Lanreotide Autogel 120 mg | Greater than or equal to 20% at week 24 (n=80) | 45 | participants | |
| Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4). | Lanreotide Autogel 120 mg | Less than 20% at week 24 (n=80) | 35 | participants | |
| Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels | Lanreotide Autogel 120 mg | Week 12 (n=85) | -43.8 | 95% Confidence Interval -50.1 to -37.5 | percentage change |
| Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels | Lanreotide Autogel 120 mg | Week 24 (n=78) | -47.4 | 95% Confidence Interval -53.6 to -41.2 | percentage change |
| Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels | Lanreotide Autogel 120 mg | Week 48 (n=62) | -56.7 | 95% Confidence Interval -62.1 to -51.3 | percentage change |
| Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels. | Lanreotide Autogel 120 mg | Week 12 (n=85) | -62.1 | 95% Confidence Interval -70.5 to -53.6 | percentage change |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| SCREENING | STARTED | Lanreotide Autogel 120 mg | 108 | |
| SCREENING | COMPLETED | Lanreotide Autogel 120 mg | 90 | |
| SCREENING | NOT COMPLETED | Lanreotide Autogel 120 mg | 18 | |
| TREATMENT | STARTED | Lanreotide Autogel 120 mg | 90 | |
| TREATMENT | COMPLETED | Lanreotide Autogel 120 mg | 64 | |
| TREATMENT | NOT COMPLETED | Lanreotide Autogel 120 mg | 26 |
Source ClinicalTrials.gov
Adverse events26
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 | Abdominal pain | Gastrointestinal disorders | Lanreotide Autogel 120 mg | 9 | 90 | 16 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Lanreotide Autogel 120 mg | 12 | 90 | 12 |
| other | Cholelithiasis 6 (6.7%) [7] | Hepatobiliary disorders | Lanreotide Autogel 120 mg | 6 | 90 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Lanreotide Autogel 120 mg | 35 | 90 | 98 |
| other | Fatigue | General disorders | Lanreotide Autogel 120 mg | 5 | 90 | 5 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Lanreotide Autogel 120 mg | 10 | 90 | 16 |
| other | Nausea | Gastrointestinal disorders | Lanreotide Autogel 120 mg | 6 | 90 | 14 |
| serious | Anaemia | Blood and lymphatic system disorders | Lanreotide Autogel 120 mg | 1 | 90 | 1 |
| serious | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Lanreotide Autogel 120 mg | 1 | 90 | 1 |
| serious | Epistaxis | Respiratory, thoracic and mediastinal disorders | Lanreotide Autogel 120 mg | 1 | 90 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanreotide Autogel 120 mg | ||
| Total, other adverse events | Lanreotide Autogel 120 mg | 72 | 90 |
| Total, serious adverse events | Lanreotide Autogel 120 mg | 13 | 90 |
Source ClinicalTrials.gov
Papers2
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.
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