DiarrheaNCT00002252
A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
A study testing Octreotide in people with Diarrhea and HIV Infections, run by Sandoz at 23 sites in United States.
Trial summary
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, HIV Infections
- What is being tested?
- Octreotide
- How many people
- Not given
- Where
- 23 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the following:
- Uncontrolled diarrhea that is either a manifestation or complication of documented HIV infection.
- Ability to communicate, participate, and comply with the requirements of the study.
- Capability of self administering injections of study medication or have responsible family member or companion who can.
- Given written consent prior to study entry.
- Prior Medication:
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- Required:
- At least two weeks of conventional dosing regimens of antidiarrheal medication (e.g.:
- Lomotil, Imodium, Paregoric) within one month prior to study entry. OR Patients with evidence of upper or lower GI infection(s) for which there is approved, potentially curative therapy must have failed appropriate treatment for at least two weeks.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Evidence of underlying immunosuppressive disease other than due to HIV.
- Diarrhea caused by a known gastrointestinal disorder such as idiopathic ulcerative colitis, Crohn's disease, acute stool culture positive bacterial colitis (documented within the last 2 weeks prior to study entry AND not having at least 2 weeks of antibiotic therapy), pseudomembranous colitis (Clostridium difficile toxin positive), short gut syndrome, chronic pancreatitis (alcoholic or idiopathic), ischemic bowel disease, or enteroenteric fistulae.
- Patients with the following are excluded:
- Diarrhea that can be controlled with conventional antidiarrheal agents.
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- Stool weight at either of the 2 baseline periods that average < 500 g/day.
- Evidence of underlying immunosuppressive disease other than due to HIV.
- Diarrhea caused by other gastrointestinal disorders not related to HIV.
- Prior Medication:
- Excluded:
- Previously treated with Sandostatin as an anti-diarrheal agent.
- Experimental antidiarrheal drugs within one month of study entry.
- Present intravenous drug abuse.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Emory Univ School of Medicine
Atlanta, Georgia, 30303
Douglas Plesko
Boston, Massachusetts, 02115
Boston City Hosp
Boston, Massachusetts, 02118
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Henry Ford Hosp
Detroit, Michigan, 48202
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Baylor College of Medicine
Houston, Texas, 77030
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
USC School of Medicine
Los Angeles, California, 90033
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792
Med Service
Miami, Florida, 33125
Mount Sinai Med Ctr
New York, New York, 10029
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Maine Med Ctr Med Clinics
Portland, Maine, 04102
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, 02906
UCSD Med Ctr
San Diego, California, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Kaiser Permanente Med Ctr
San Francisco, California, 94115
San Mateo County Gen Hosp
San Mateo, California, 94403
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, 117948121
Einstein Med School
The Bronx, New York, 10461
About this study
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes.
- Conditions
- Diarrhea, HIV Infections
- Being tested
- Octreotide
- Keywords
- Octreotide, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Medical subject headings
- Diarrhea, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002252
- Sponsor's protocol ID
- 102A
- Other IDs
- D203
- Status last verified
- Aug 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Romeu J, Miro JM, Mallolas J, Sirera G, Tortosa F, Clotet B. Sandostatin (SMS-201-995) in the long-term management of chronic diarrhea in AIDS patients. Int Conf AIDS. 1991 Jun 16-21;7(2):272 (abstract no WB2362)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
- ClinicalTrials.gov ID
- NCT00002252
- Acronym / sponsor ID
- 102A
- Conditions
- Diarrhea, HIV Infections
- Keywords
- Octreotide, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Uncontrolled diarrhea that is either a manifestation or complication of documented HIV infection.
- Ability to communicate, participate, and comply with the requirements of the study.
- Capability of self administering injections of study medication or have responsible family member or companion who can.
- Given written consent prior to study entry.
- At least two weeks of conventional dosing regimens of antidiarrheal medication (e.g.:
Key exclusion criteria (14 listed)
- Evidence of underlying immunosuppressive disease other than due to HIV.
- Diarrhea caused by a known gastrointestinal disorder such as idiopathic ulcerative colitis, Crohn's disease, acute stool culture positive bacterial colitis (documented within the last 2 weeks prior to study entry AND not having at least 2 weeks of antibiotic therapy), pseudomembranous colitis (Clostridium difficile toxin positive), short gut syndrome, chronic pancreatitis (alcoholic or idiopathic), ischemic bowel disease, or enteroenteric fistulae.
- Diarrhea that can be controlled with conventional antidiarrheal agents.
- Stool weight at either of the 2 baseline periods that average < 500 g/day.
- Evidence of underlying immunosuppressive disease other than due to HIV.
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 |
|---|---|---|
| Octreotide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundRomeu J, Miro JM, Mallolas J, Sirera G, Tortosa F, Clotet B. Sandostatin (SMS-201-995) in the long-term management of chronic diarrhea in AIDS patients. Int Conf AIDS. 1991 Jun 16-21;7(2):272 (abstract no WB2362)
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octreotide in people with Diarrhea and HIV Infections, run by Sandoz at 23 sites in United States.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002252, which also lists 1 linked publication.
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 24 Jun 2005.