A study of the efficacy and safety of Genotonorm in short stature patients with a history of intrauterine growth retardation. A two-year, open randomized study. Genetic-molecular and biochemical-hormonal evaluation.
| DEC-NET Serial number ES396 | |
| Published online | 03/05/2005 13.21.00 |
| Last updated | 21/04/2006 14.51.42 |
| Other protocol ID number | RCIU 307-MET-0021-003 |
| Current trial status | Complete(closed to recruitment of participants: follow-up complete) |
| Major Disease (ICD9 class) | FETAL GROWTH RETARDATION UNSPECIFIED WEIGHT |
| Experimental drug | |
| Growth hormone | |
| Gender | Both |
| Age (range) | Over 3 years old |
Eligibility criteria | |
| Inclusion criteria | |
| Boys or girls with a history of intrauterine growth retardation assessed as body weight and/or stature at birth | |
| Exclusion criteria | |
| GH secretion < 10 ng/ml after pharmacological test; post-ischemic neonatal enceophalopathy; associated endocrine pathology, except hypothyroidism with substitution therapy; chronic steroid treatment; serious chronic illness (blood pathology, pulmonary disease, liver pathology, malabsortion, neurological alterations, etc); neoplasms; a history of intracranial radiation; syndromes except Sylver-Russell; chromosomal alterations; patients previously treated with growth hormone. | |
Trial design/methodology | |
| Phase | 4 |
| Kind of study | Efficacy Safety |
| Design | Controlled Randomised |
| Purpose of study | |
| The primary objective is to study the efficacy on growth in Standard Deviation Score (SDS) of stature and the genetic-molecular and metabolic-hormonal status of intrauterine growth retardation. The secondary objective is to study the efficacy and safety of Genotonorm. | |
| Primary outcomes | |
| SDS (Standard Deviation Score) of the height. | |
| Secondary outcomes | |
| Auxologic data Bone age | |
| Principal investigator | |
| Name | Antonio Carrascosa |
| Institution | Hospital Infantil Vall d'Hebron. Servicio de Pediatría. |
| Postal address | Paseo Vall d'Hebron, 119-129. |
| City | Barcelona (08035) |
| Country | SPAIN |
| Phone | +34 93 489 30 64 |
| Fax | +34 93 489 30 65 |
| Promoter |
| Pfizer, S.A. (Industry) |
| Participating centres |
| Hosp. Vall d'Hebron (Barcelona) |
| Hosp. Santa Creu i Sant Pau (Barcelona) |
| Hosp. Sant Joan de Déu (Barcelona) |
| Hosp. Sagrat Cor (Barcelona) |
| Hosp. Germans Trias i Pujol (Badalona (Barcelona)) |
| Hosp. de Terrassa (Terrassa (Barcelona)) |
| Hosp. Parc Taulí (Sabadell (Barcelona)) |
| Hosp. General de Granollers (Granollers (Barcelona)) |
| Hosp. Sant Joan de Reus (Reus (Tarragona)) |
| Hosp. General de Valencia (Valencia) |
| Hosp. Materno-Infantil Son Dureta (Mallorca) |
| Hosp. Arnau de Vilanova (Lleida) |
| Hosp. Miguel Servet (Zaragoza) |
| Hosp. de Cruces (Baracaldo (Vizcaya)) |
| Hosp. de Basurto (Bilbao) |
| Hosp. Marqués de Valdecilla (Santander) |
| Hosp. La Paz (Madrid) |
| Hosp. 12 de Octubre (Madrid) |
| Hosp. Universitario de Getafe (Getafe (Madrid)) |
| Hosp. Gregorio Marañón (Madrid) |
| Hosp. Virgen de la Salud (Toledo) |
| Hosp. de Txagorritxu (Vitoria) |
| Hosp. Virgen de las Nieves (Granada) |
| Hosp. Materno-Inf. de Málaga Carlos Haya (Málaga) |
| Hosp. Universitario Reina Sofía (Córdoba) |
| Hosp. Virgen del Rocío (Sevilla) |
| Hosp. Puerta del Mar (Cádiz) |
| Hosp. Ntra. Sra. de la Candelaria (Sta. Cruz de Tenerife) |
| Hosp. General Yagüe (Burgos) |
| Hosp. Universitario de Canarias (Sta. Cruz de Tenerife) |
| ISRCTN | EudraCT |
