Diabetic GastroparesisPhase 2NCT02289846
Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
A Phase 2 study testing IW-9179 in people with Diabetic Gastroparesis, run by Ironwood Pharmaceuticals, Inc. at 22 sites in United States.
Trial summary
The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- IW-9179
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 22 sitesUnited States
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 2
- 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
- Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit.
- Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus.
- Patient has a diagnosis of DGP with no history or evidence of mechanical obstruction, symptoms for at least 3 consecutive months preceding the Screening Visit, and delayed gastric emptying of solids documented within 2 years of the Screening Visit.
- Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient's gastroduodenal symptoms.
- Patient is compliant with eDiary completion.
- Patient agrees to refrain from making any new, major lifestyle changes.
- Patient is fluent and literate in English.
Who cannot join
- Patient has a history or current symptoms of any organic or structural disease that, in the opinion of the investigator, can cause abdominal pain or discomfort and may confound the assessment of DGP symptoms.
- Patients with rumination syndrome, cyclic vomiting syndrome, anorexia nervosa, or bulimia.
- Patient is currently using a gastric electric stimulator or has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
- Patient has been hospitalized within the 2 months prior to the Screening Visit for uncontrolled diabetes mellitus, DGP, or associated malnutrition.
- Patient reports significant diarrhea during the four weeks prior to the Screening Visit, or more than 2 days during either week of the Pretreatment Period.
- Patient has had surgery of the GI tract any time before the Screening Visit, an appendectomy or cholecystectomy during the 3 months before the Screening Visit, non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months, or other major non-GI surgery during the 30 days before the Screening Visit.
- Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable).
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Ironwood Investigational Site
Bastrop, Louisiana, 71220
Ironwood Investigational Site
Birmingham, Alabama, 35203
Ironwood Investigational Site
Chattanooga, Tennessee, 37421
Ironwood Investigational Site
Chesterfield, Michigan, 48047
Ironwood Investigational Site
Chula Vista, California, 91910
Ironwood Investigational Site
Dothan, Alabama, 36305
Ironwood Investigational Site
Great Neck, New York, 11023
Ironwood Investigational Site
Greensboro, North Carolina, 27410
Ironwood Investigational Site
Houston, Texas, 77015
Ironwood Investigational Site
Los Angeles, California, 90036
Ironwood Investigational Site
Miami, Florida, 33122
Ironwood Investigational Site
New York, New York, 10018
Ironwood Investigational Site
North Little Rock, Arkansas, 72117
Ironwood Investigational Site
Ogden, Utah, 84405
Ironwood Investigational Site
Poughkeepsie, New York, 12601
Ironwood Investigational Site
Rochester, Minnesota, 55905
Ironwood Investigational Site
Tampa, Florida, 33607
Ironwood Investigational Site
Tucson, Arizona, 85710
Ironwood Investigational Site
Urbana, Illinois, 61801
Ironwood Investigational Site
Ventura, California, 93003
Ironwood Investigational Site
Webster, Texas, 77598
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis
The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.
- Conditions
- Diabetic Gastroparesis
- Being tested
- IW-9179, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-9179Drug
Matching PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo BID | Placebo comparator | Placebo once in the morning and once in the evening. Receives: Drug: Matching Placebo |
| IW-9179 QD AM + Placebo QD PM | Experimental | IW-9179 once in the morning and placebo once in the evening. Receives: Drug: IW-9179; Drug: Matching Placebo |
| Placebo QD AM + IW-9179 QD PM | Experimental | Placebo once in the morning and IW-9179 once in the evening. Receives: Drug: IW-9179; Drug: Matching Placebo |
| IW-9179 BID | Experimental | IW-9179 once in the morning and once in the evening Receives: Drug: IW-9179 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
Measured: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Diabetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289846
- Sponsor's protocol ID
- ICP-112-202
- Status last verified
- Jan 2016
- First submitted
- 10 Nov 2014
- Last updated
- 5 Dec 2016
- Results posted
- No
Publications
Ervin CM, Reasner DS, Hanlon JT, Fehnel SE. Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews. Adv Ther. 2017 Dec;34(12):2680-2692. doi: 10.1007/s12325-017-0632-6. Epub 2017 Oct 27.
PubMed 29079987
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT02289846
- Acronym / sponsor ID
- ICP-112-202
- Conditions
- Diabetic Gastroparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Nov 2014 (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 objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo BID | Placebo comparator | Drug: Matching PlaceboPlacebo once in the morning and once in the evening. |
| IW-9179 QD AM + Placebo QD PM | Experimental | Drug: IW-9179, Drug: Matching PlaceboIW-9179 once in the morning and placebo once in the evening. |
| Placebo QD AM + IW-9179 QD PM | Experimental | Drug: IW-9179, Drug: Matching PlaceboPlacebo once in the morning and IW-9179 once in the evening. |
| IW-9179 BID | Experimental | Drug: IW-9179IW-9179 once in the morning and once in the evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit.
- Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus.
- Patient has a diagnosis of DGP with no history or evidence of mechanical obstruction, symptoms for at least 3 consecutive months preceding the Screening Visit, and delayed gastric emptying of solids documented within 2 years of the Screening Visit.
- Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient's gastroduodenal symptoms.
- Patient is compliant with eDiary completion.
Key exclusion criteria (7 listed)
- Patient has a history or current symptoms of any organic or structural disease that, in the opinion of the investigator, can cause abdominal pain or discomfort and may confound the assessment of DGP symptoms.
- Patients with rumination syndrome, cyclic vomiting syndrome, anorexia nervosa, or bulimia.
- Patient is currently using a gastric electric stimulator or has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
- Patient has been hospitalized within the 2 months prior to the Screening Visit for uncontrolled diabetes mellitus, DGP, or associated malnutrition.
- Patient reports significant diarrhea during the four weeks prior to the Screening Visit, or more than 2 days during either week of the Pretreatment Period.
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 |
|---|---|---|
| IW-9179 | Drug | IW-9179 BID, IW-9179 QD AM + Placebo QD PM, Placebo QD AM + IW-9179 QD PM |
| Matching Placebo | Drug | IW-9179 QD AM + Placebo QD PM, Placebo BID, Placebo QD AM + IW-9179 QD PM |
Primary outcome
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
Time frame: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
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 5 Dec 2016.
- Derived from this study: PubMed 29079987Ervin CM, Reasner DS, Hanlon JT, Fehnel SE. Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews. Adv Ther. 2017 Dec;34(12):2680-2692. doi: 10.1007/s12325-017-0632-6. Epub 2017 Oct 27.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IW-9179 in people with Diabetic Gastroparesis, run by Ironwood Pharmaceuticals, Inc. at 22 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 7 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms (time frame: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289846, 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 5 Dec 2016.