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NCT01167075: Intestamin
A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
NA trial testing Fresubin Original in Critical Illness in 58 participants. Completed in 1 February 2009.
1 February 2009
Quick facts
| Lead sponsor | Hannover Medical School |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 58 |
| Start date | 1 February 2006 |
| Primary completion | 1 February 2009 |
| Estimated completion | 1 February 2009 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Fresubin Original
- Intestamin plus Fresubin Original
Conditions studied
- Critical Illness — all drugs for Critical Illness →
- Adult — all drugs for Adult →
- Sepsis — all drugs for Sepsis →
- Systemic Inflammatory Response Syndrome — all drugs for Systemic Inflammatory Response Syndrome →
Sponsor
Hannover Medical School
Who can join
Adults 18 to 75, any sex, with Critical Illness or Adult. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Length of stay in ICU
Time frame: 14 days
The primary endpoints were length of stay in ICU and sufficient enteral feed.
Sponsor's own description
The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01167075
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hannover Medical School trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01167075 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hannover Medical School
- Last refreshed: 21 July 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01167075.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing