Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients

NCT00642720 | Completed Phase 4

• 2 other identifiers: *P05.1649L*P05.1649L CCMO
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during long-term treatment with long-acting somatostatin analogs Study Objectives:

• Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i.m. or patients on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s.c. will be enrolled.
• For 4 months, all subjects will also receive weekly s.c. injections of either placebo or a fixed dose of 40 mg pegvisomant
• After a 4 weeks wash-out period, patients will switch from either placebo to pegvisomant or from pegvisomant to placebo
• Before, and after 2 and 4 months of each treatment period, serum efficacy parameters and quality of life (AcroQol ™/ PASQ™) will be assessed.
• Before and after 4 months of each treatment period, pituitary tumor size and insulin sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months Hypothesis:
• We postulate that co-administration of the growth hormone receptor antagonist pegvisomant will improve QoL and insulin sensitivity

Conditions

Quality of Life; Acromegaly

Outcome Measures

Primary Outcomes (1)

• To assess if the addition of pegvisomant weekly will improve Quality of life (QoL). QoL will be assessed by the PASQ and AcroQol questionnaires

  at 8 and 16 weeks of treatment

Secondary Outcomes (1)

• If the addition of pegvisomant will improve metabolic parameters such as Insulin sensitivity, lipids, Glucose, IGF-I ect.

  at 8 and 16 weeks

Study Arms (2)

pegvisomant-placebo

OTHER

patients in this arm received(as addition)for the first 8 weeks Pegvisomant and the later for 8 weeks Placebo. This was divided by a 4 weeks wash-out period.

Drug: Pegvisomant

placebo-pegvisomant

OTHER

Patient received for the first 8 weeks Pegvisomant and after a wash out period of 4 weeks the received 8 of placebo treatment

Drug: Pegvisomant

Interventions

Pegvisomant DRUG

if the addition of 40 mg pegvisomant weekly will improve the quality of life of acromegaly patients compared to placebo weekly

pegvisomant-placebo; placebo-pegvisomant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active acromegaly.
• Serum total IGF-I levels must have been normalized during long-term treatment with long-acting somatostatin analogs
• Age between 18 and 80

You may not qualify if:

• Any contra-indication for the use of long-acting somatostatin analogs, as e.g. the use of anti-coagulants.
• Subjects with pituitary tumors that compress the optic chiasm
• Patients with insulin dependent diabetes
• Patients with cancer
• Patients with kidney- or liver function disturbances
• Fertile female patients that refuse to take contraceptives during the study

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Acromegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 25, 2008
• Study Start: October 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 25, 2008

Record last verified: 2008-03