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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Acromegaly Combination Treatment Study

NCTNCT01538966 (opens ClinicalTrials.gov in a new tab)Other idPro26424Other idWS2036536

Overview

Status
Terminated
Phase
Not applicable
Enrollment
76 participants (actual)
Sponsor
Cedars-Sinai Medical Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
29 Mar 2012
Primary completion
20 May 2022
Completion
20 May 2022
First posted
27 Feb 2012 (estimated)
Last update posted
4 Jan 2023
Conditions
Acromegaly

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220142016201820202022
  1. N/A

    Acromegaly Combination Treatment Study

    NCT01538966

    29 Mar 2012 to 20 May 2022

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.

Interventions

  • PegvisomantDrug
  • Octreotide LARDrug
  • LanreotideDrug

Arms3

  • Active comparator

    High dose SRL + weekly Pegvisomant

    High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)

  • Active comparator

    Low dose SRL + daily Pegvisomant

    Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)

  • Active comparator

    Low dose SRL + weekly Pegvisomant

    Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cost Effectiveness

    Time frame · 24 weeks

    Registry description

    We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 weeks

Cost Effectiveness

GroupValue (US dollars/month)Spread
High Dose SRL + Weekly Pegvisomant14,261.331,645.49
Low Dose SRL + Daily Pegvisomant22,542.8611,158.49
Low Dose SRL + Weekly Pegvisomant9,836.521,374.99

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
High Dose SRL + Weekly PegvisomantHigh dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)0 / 150 / 154 / 15
Low Dose SRL + Daily PegvisomantLow dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)0 / 140 / 142 / 14
Low Dose SRL + Weekly PegvisomantLow dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)0 / 231 / 239 / 23

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2020

Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial.

Bonert et al. 2020The Journal of clinical endocrinology and metabolismcited by 40

PMID 32754748DOI 10.1210/clinem/dgaa444PUB-32754748

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Newly diagnosed patients with acromegaly who have not had surgery or medical therapy * Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy * Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels * Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels. * Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist. * Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly * Normal liver function tests before randomization to treatment * The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy. Exclusion Criteria: * The patient harbors a macroadenoma with visual field defects due to chiasmatic compression * The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit. * The patient had pituitary surgery within 3 months prior to study entry * The patient had radiotherapy within 12 months prior to study entry * The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety. * The patient has a known hypersensitivity to any of the test materials or related compounds. * The patient has a history of, or known current problems with alcohol or drug abuse. * The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.

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