Ulcerative ColitisPhase 1NCT01020708
Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
A Phase 1 study testing mesalamine, ALTH12-1:4 and ALTH12-2:4 in people with Ulcerative Colitis, run by Altheus Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- mesalamine, ALTH12-1:4 and ALTH12-2:4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2010
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years
- They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild active disease or disease in remission.
- Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI with a sigmoidoscopy score of 1 point or less and Physician's rating of disease score of 1 point or less (mild or remission).
- Laboratory data:
- White blood cell count between 4,500 and 10,000 cells/mL
- Platelet count: 150,000-450,000 cells/mL
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- Hemoglobin > 10.0 g/dL
- Total bilirubin < 1.5 mg/dL
- Aspartate aminotransferase < 100 u/dL
- Alanine aminotransferase < 100 u/dL
- Alkaline phosphatase < 250 u/dL
- Blood urine nitrogen < 40 mg/dL
- Creatinine < 1.5 mg/dL
- Amylase < 150 U/L
- Satisfied one of the following:
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.
- Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.
- They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Who cannot join
- Subjects will be excluded if:
- They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
- They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- They receive a Physician's rating of disease severity as part of the modified UCDAI of 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
- They have shown evidence of high grade dysplasia on endoscopic examinations.
- Their stool contains enteric pathogens or Clostridium difficile toxins.
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- They have a history of recurrent Clostridium difficile infection.
- They have prior history of biologic therapy.
- They have received systemic steroids or immunosuppressants within the previous 4 weeks.
- Treatment in the last 2 weeks that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) and/or 5-ASA enema (e.g. Rowasa®).
- They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
- Positive pregnancy test or lactating subjects.
- There is evidence of chemical abuse.
- They have a known allergy to N-acetylcysteine or Mesalamine.
- They have a history of failure to retain enemas.
- Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
- Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis
This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9 patients will be enrolled in this study, allowing for up to 3 replacement or additional patients.
- Conditions
- Ulcerative Colitis
- Being tested
- mesalamine, ALTH12-1:4, ALTH12-2:4
- Keywords
- colitis, inflammatory bowel disease, ulcerative colitis, rectal administration, enema, mesalamine
- Medical subject headings
- Colitis, Ulcerative, Colitis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesalamineDrug
Also called Rowasa, 5-ASA, 5-aminosalicylic acid
4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily
ALTH12-1:4Drug
Also called mesalamine, 5-ASA, N-acetylcysteine, NAC
ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine
ALTH12-2:4Drug
Also called mesalamine, 5-ASA, N-acetylcysteine, NAC
ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Mesalamine enema Receives: Drug: mesalamine |
| ALTH12-1:4 | Experimental | ALTH12-1:4 experimental treatment dose Receives: Drug: ALTH12-1:4 |
| ALTH12-2:4 | Experimental | ALTH12-2:4 experimental treatment dose Receives: Drug: ALTH12-2:4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon
Measured: 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altheus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip B Miner, M.D., Principal investigator, Oklahoma Foundation for Digestive Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020708
- Sponsor's protocol ID
- ALTH12-003
- Status last verified
- Mar 2011
- First submitted
- 20 Nov 2009
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01020708
- Acronym / sponsor ID
- ALTH12-003
- Conditions
- Ulcerative Colitis
- Keywords
- colitis, inflammatory bowel disease, ulcerative colitis, rectal administration, enema, mesalamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Altheus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Nov 2009 (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.
This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9 patients will be enrolled in this study, allowing for up to 3 replacement or additional patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Drug: mesalamineMesalamine enema |
| ALTH12-1:4 | Experimental | Drug: ALTH12-1:4ALTH12-1:4 experimental treatment dose |
| ALTH12-2:4 | Experimental | Drug: ALTH12-2:4ALTH12-2:4 experimental treatment dose |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years
- They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild active disease or disease in remission.
- Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI with a sigmoidoscopy score of 1 point or less and Physician's rating of disease score of 1 point or less (mild or remission).
- Laboratory data:
- Satisfied one of the following:
Key exclusion criteria (17 listed)
- They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
- They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- They receive a Physician's rating of disease severity as part of the modified UCDAI of 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
- They have shown evidence of high grade dysplasia on endoscopic examinations.
- Their stool contains enteric pathogens or Clostridium difficile toxins.
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 |
|---|---|---|
| mesalamineAlso: Rowasa, 5-ASA, 5-aminosalicylic acid4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily | Drug | Comparator |
| ALTH12-1:4Also: mesalamine, 5-ASA, N-acetylcysteine, NACALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine | Drug | ALTH12-1:4 |
| ALTH12-2:4Also: mesalamine, 5-ASA, N-acetylcysteine, NACALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine | Drug | ALTH12-2:4 |
Primary outcome
To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon
Time frame: 6 weeks treatment
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 29 Mar 2011.
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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.
Philip B Miner, M.D. principal investigator
Oklahoma Foundation for Digestive Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesalamine, ALTH12-1:4 and ALTH12-2:4 in people with Ulcerative Colitis, run by Altheus Therapeutics, Inc. at 1 site 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 18 inclusion and 17 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 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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.
What does the primary outcome measure?
To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon (time frame: 6 weeks treatment). 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 29 Mar 2011.