GastroparesisPhase 1NCT00639808
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
A Phase 1 study testing 5% dextrose in water and TZP-101 in people with Gastroparesis and Diabetes Mellitus, run by Tranzyme, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroparesis, Diabetes Mellitus
- What is being tested?
- 5% dextrose in water and TZP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2006to Mar 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has type 1 or type 2 diabetes mellitus
- Subject has documented diagnosis of gastroparesis by:
- Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
- A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
- Subject has normal upper endoscopy
- If female, must be permanently sterilized or postmenopausa.
Who cannot join
- Patient has received any investigational drug within the preceding 30 days
- Patient is taking unstable doses of medication that affects gastric motility
- Patient has co-morbid condition
- Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
- Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
- Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
- Patient has known history of alcoholism
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients
The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.
- Conditions
- Gastroparesis, Diabetes Mellitus
- Being tested
- 5% dextrose in water, TZP-101
- Keywords
- delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% dextrose in waterDrug
Also called D5W
60 ml IV infusion over 30 minutes
TZP-101Drug
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: 5% dextrose in water |
| 2 | Experimental | TZP-101 Receives: Drug: TZP-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-lead ECG data
Measured: 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.
Secondary outcomes (1)
Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal
Measured: Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startAug 2006
- Primary completionJul 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tranzyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639808
- Sponsor's protocol ID
- TZP-101-CL-002
- Other IDs
- EudraCT 2006-002730-38
- Status last verified
- Mar 2008
- First submitted
- 13 Mar 2008
- Last updated
- 20 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients
- ClinicalTrials.gov ID
- NCT00639808
- Acronym / sponsor ID
- TZP-101-CL-002
- Conditions
- Gastroparesis, Diabetes Mellitus
- Keywords
- delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tranzyme, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Mar 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 purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: 5% dextrose in water |
| 2 | Experimental | Drug: TZP-101TZP-101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has type 1 or type 2 diabetes mellitus
- Subject has documented diagnosis of gastroparesis by:
- Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
- A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
- Subject has normal upper endoscopy
Key exclusion criteria (7 listed)
- Patient has received any investigational drug within the preceding 30 days
- Patient is taking unstable doses of medication that affects gastric motility
- Patient has co-morbid condition
- Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
- Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
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 |
|---|---|---|
| 5% dextrose in waterAlso: D5W60 ml IV infusion over 30 minutes | Drug | 1 |
| TZP-1011 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg | Drug | 2 |
Primary outcome
12-lead ECG data
Time frame: 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.
1 secondary outcome
Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal
Time frame: Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten
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 20 Mar 2008.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5% dextrose in water and TZP-101 in people with Gastroparesis and Diabetes Mellitus, run by Tranzyme, Inc. at 3 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 20 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Sweden. 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 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?
12-lead ECG data (time frame: 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.). 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 20 Mar 2008.