SteatorrheaPhase 3NCT00623025
Creon in HIV Patients With Steatorrhea
A Phase 3 study testing Creon 25000 in people with Steatorrhea, run by Abbott at 2 sites in Romania.
Trial summary
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Steatorrhea
- What is being tested?
- Creon 25000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesRomania
- Study dates
- Jan 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Known allergy to pancreatin or any history of abnormal drug reaction;
- Known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy;
- Intake of an experimental drug within four weeks prior to entry into the study;
- Alcohol abuse within the last six months;
- Suspected non-compliance or non-cooperation;
- Any other lack of fitness, in the investigator's opinion, to participate in or to complete the study;
- Patients with a stool fat excretion <= 7 g/day according to van de Kamer during the run-in period
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Site Reference ID/Investigator# 59364
Bucharest, 021105
Site Reference ID/Investigator# 59363
Craiova, 200515
About this study
Official title: Double-blind, Cross-over, Randomized, Placebo-controlled, Multi-center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-infected Patients
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
- Conditions
- Steatorrhea
- Being tested
- Creon 25000, Placebo
- Keywords
- HIV, Steatorrhea
- Medical subject headings
- Steatorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creon 25000Drug
6 to 9 capsules Creon 25000 per day
PlaceboDrug
6 to 9 capsules placebo per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Creon 25000 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of fat absorption (CFA)
Measured: After 2 weeks
Secondary outcomes (4)
Stool fat excretion
Measured: After 2 weeks
Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
Measured: After 2 weeks
Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline
Measured: After 2 weeks
Stool weight
Measured: After 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Discontinued prematurely due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Suntje Sander, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623025
- Sponsor's protocol ID
- S245.3.125
- Other IDs
- 2007-005433-11, 00623025
- Status last verified
- Jul 2011
- First submitted
- 14 Feb 2008
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Cross-over, Randomized, Placebo-controlled, Multi-center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-infected Patients
- ClinicalTrials.gov ID
- NCT00623025
- Acronym / sponsor ID
- S245.3.125
- Conditions
- Steatorrhea
- Keywords
- HIV, Steatorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued prematurely due to low enrollment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Creon 25000 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Known allergy to pancreatin or any history of abnormal drug reaction;
- Known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy;
- Intake of an experimental drug within four weeks prior to entry into the study;
- Alcohol abuse within the last six months;
- Suspected non-compliance or non-cooperation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creon 250006 to 9 capsules Creon 25000 per day | Drug | 1 |
| Placebo6 to 9 capsules placebo per day | Drug | 2 |
Primary outcome
Coefficient of fat absorption (CFA)
Time frame: After 2 weeks
4 secondary outcomes
Stool fat excretion
Time frame: After 2 weeks
Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
Time frame: After 2 weeks
Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline
Time frame: After 2 weeks
Stool weight
Time frame: After 2 weeks
Results and safety
The study was stopped early (reason given: Discontinued prematurely due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
Related trials for Steatorrhea
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suntje Sander, PhD study director
Abbott
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Creon 25000 in people with Steatorrhea, run by Abbott at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Discontinued prematurely due to low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of fat absorption (CFA) (time frame: After 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.