Trial · NCT00383708
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
NCT00383708, Phase 3, Completed, Ipsen; results first posted 2018-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients. Trials, record NCT00383708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00383708
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
- NCT number
- NCT00383708
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 125 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Acromegaly
- Interventions
- lanreotide (Autogel formulation), Pegvisomant
- First posted
- 2006-10-03
- Last updated
- 2022-09-27
- Results first posted
- 2018-07-23
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at Visit (V) 1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to investigational medicinal product (IMP) administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period are presented. The last observation carried forward (LOCF) was used to replace missing IGF-1 values. |
| Primary | Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | V3 (Week 12; Baseline) up to V11 (Week 44) | Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by previous treatment and by final pegvisomant dose are presented. The denominator used to calculate percentages was the number of subjects in each subgroup, comprising previous treatment with pegvisomant, lanreotide Autogel and octreotide long acting repeatable (LAR) and final pegvisomant dose as either 40 mg, 60 mg or 80 mg once a week or 40 mg or 60 mg twice per week. The LOCF approach was used to replace missing IGF-1 values. |
| Primary | Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline | V3 (Week 12; Baseline) up to V11 (Week 44) | Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by diabetic status are presented. The denominator used to calculate percentages was the number of subjects in each subgroup (diabetic and non diabetic). The LOCF approach was used to replace missing IGF-1 values. |
| Secondary | Percentage of Subjects With a Normalised (Age and Sex Adjusted) IGF-1 Level at Any Time During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at least once during the co-administration period, summarised by 'while taking the final dose during co-administration' and 'at any time during co-administration' are presented. |
| Secondary | Percentage of Subjects With Normalised (Age and Sex Adjusted) IGF-1 at Each Assessment | V1 (Screening) up to V11 (Week 44) | Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. The percentage of subjects with a normalised (age and sex adjusted) IGF-1 level is presented. The denominator used to calculate the percentages was the number of ITT population subjects with an assessment at the visit. In addition to the data for each individual visit, the last value available (LVA) data is also presented. None of the ITT population subjects had serum IGF-1 normalised at V3, consistent with the criterion to continue in the study and be treated in the co-administration period. |
| Secondary | Change From Baseline in Serum IGF-1 Levels (Expressed as Z-scores) During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The change in serum IGF-1 levels, expressed as z-scores calculated using the age and sex specific mean and standard deviation \[SD\] values from Baseline to V11 and to LVA are presented. A z-score between +/- 2 indicates a normal IGF-1 concentration. |
| Secondary | Change From Baseline in Acromegaly Symptoms During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | Acromegaly symptoms, including arthralgia, excessive perspiration, fatigue, headache and soft tissue swelling were assessed with scores ranging from 0 (no symptoms) to 8 (severe, incapacitating symptoms). Symptoms were assessed by the subject in paper format before any other procedure planned during the visit. The change in acromegaly symptoms from Baseline to V11 and to LVA are presented. |
| Secondary | Change From Baseline in Acromegaly Quality of Life (ACROQoL) Assessments During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ACROQoL is a health-related quality of life (QoL) questionnaire for patients with acromegaly consisting of 22 items measured on a 5-point Likert-type scale that assesses frequency of occurrence (always to never) or degree of agreement (completely agree to completely disagree) with the statements. The ACROQoL consists of questions that evaluate physical (8 items) and psychological aspects related to appearance and personal relations (7 items each). Answers are transformed to a percentage value, where 100 is the maximal (best) and 0 the minimum (worse) score depicting self-perceived quality QoL. An increase in ACROQoL score is associated with an improved QoL. The change in ACROQoL global score, physical and psychological dimension scores and appearance and personal relationships sub-dimension scores from Baseline to V11 and to LVA are presented. Relnship = Relationship; Dim = Dimension. |
| Secondary | Correlation Between the Changes in ACROQoL Assessments With the Corresponding Changes in Z-score of IGF-1 Levels Over the Run-in Period and Co-administration Period | At V2 (Day 1; Run-in), V3 (Week 12; Baseline) and V11 (Week 44) | The correlation between the changes in ACROQoL (expressed as standardised scores and undertaken for global score, physical and psychological dimension scores and appearance and personal relationships sub-dimension scores) over the run-in period (V3 minus V2) and co-administration period (V11 and LVA minus V3) with the corresponding changes in z-score for the IGF-1 level is presented. A decrease in IGF-1 z-score represents an improvement and an increase in ACROQoL score represents an improvement. Spearman's rank correlation (r) values are presented for change from V2 to V3 (Baseline) and from Baseline to V11/LVA for each of the specified ACROQoL categories. Corr = Correlation; Dim = Dimension; Relnship = Relationship. |
| Secondary | Change From Baseline in Mean Weight From Baseline During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | Weight was recorded at V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean weight from Baseline to V11 and to LVA are presented. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects within each individual subgroup analysed for each category. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects within each of the two subgroups analysed for each category. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With a Normalised (Age and Sex Adjusted) IGF-1 Level at Any Time During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Normalised (Age and Sex Adjusted) IGF-1 at Each Assessment | V1 (Screening) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Serum IGF-1 Levels (Expressed as Z-scores) During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis. | z-score | MEAN |
| SECONDARY | Change From Baseline in Acromegaly Symptoms During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Acromegaly Quality of Life (ACROQoL) Assessments During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis. | units on a scale | MEAN |
| SECONDARY | Correlation Between the Changes in ACROQoL Assessments With the Corresponding Changes in Z-score of IGF-1 Levels Over the Run-in Period and Co-administration Period | At V2 (Day 1; Run-in), V3 (Week 12; Baseline) and V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. | correlation value | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Serum GH Levels During the Co-administration Period | V3 (Week 12; Baseline) up to V11 (Week 44) | The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis. | nanograms per millilitre (ng/mL) | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group119
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period | Lanreotide Autogel + Pegvisomant Co-administration | 57.9 | percentage of subjects | ||
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Previous Treatment: Pegvisomant | 46.2 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Previous Treatment: Lanreotide Autogel | 54.2 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Previous Treatment: Octreotide LAR | 70.0 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Final Dose Pegvisomant: 40 mg/week | 76.9 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Final Dose Pegvisomant: 60 mg/week | 61.5 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Final Dose Pegvisomant: 80 mg/week | 75.0 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Final Dose Pegvisomant: 40 mg 2x/week | 60.0 | percentage of subjects | |
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant | Lanreotide Autogel + Pegvisomant Co-administration | Final Dose Pegvisomant: 60 mg 2x/week | 0 | percentage of subjects | |
| Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline | Lanreotide Autogel + Pegvisomant Co-administration | Diabetic Subjects | 47.4 | percentage of subjects |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolment Through Start Treatment | STARTED | All Subjects | 125 | |
| Enrolment Through Start Treatment | COMPLETED | All Subjects | 92 | |
| Enrolment Through Start Treatment | NOT COMPLETED | All Subjects | 33 | |
| Run-in Period | STARTED | All Subjects | 92 | |
| Run-in Period | COMPLETED | All Subjects | 85 | |
| Run-in Period | NOT COMPLETED | All Subjects | 7 | |
| Co-administration Period | STARTED | All Subjects | 57 | |
| Co-administration Period | COMPLETED | All Subjects | 52 | |
| Co-administration Period | NOT COMPLETED | All Subjects | 5 |
Source ClinicalTrials.gov
Adverse events74
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 | Injection site nodule | General disorders | Run-in Period | 1 | 57 | 1 |
| other | Injection site nodule | General disorders | Co-administration Period | 2 | 57 | 2 |
| other | Injection site pain | General disorders | Run-in Period | 2 | 57 | 2 |
| other | Injection site pain | General disorders | Co-administration Period | 0 | 57 | 0 |
| other | Injection site erythema | General disorders | Run-in Period | 0 | 57 | 0 |
| other | Injection site erythema | General disorders | Co-administration Period | 2 | 57 | 4 |
| other | Depression | Psychiatric disorders | Run-in Period | 2 | 57 | 2 |
| other | Depression | Psychiatric disorders | Co-administration Period | 0 | 57 | 0 |
| other | Alanine aminotransferase increased | Investigations | Run-in Period | 0 | 57 | 0 |
| other | Alanine aminotransferase increased | Investigations | Co-administration Period | 2 | 57 | 2 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Period | 0 | 57 |
| Total, all-cause mortality | Co-administration Period | 0 | 57 |
| Total, other adverse events | Run-in Period | 30 | 57 |
| Total, other adverse events | Co-administration Period | 41 | 57 |
| Total, serious adverse events | Run-in Period | 2 | 57 |
| Total, serious adverse events | Co-administration Period | 8 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21148630 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Run-in Period vs Co-administration Period: deaths from any cause | Trial comparisons |
| Run-in Period vs Co-administration Period: serious adverse events | Trial comparisons |
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/NCT00383708
GET https://conductscience.org/api/trials/v1/NCT00383708/registered?page=2