Idiopathic GastroparesisPhase 3NORIGNCT00765895
Nortriptyline for Idiopathic Gastroparesis
A Phase 3 study testing Nortriptyline Hydrochloride in people with Idiopathic Gastroparesis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in United States.
Trial summary
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Idiopathic Gastroparesis
- What is being tested?
- Nortriptyline Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2009to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 through 65 years old at registration
- Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
- Symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or greater
- Negative upper endoscopy or upper GI series within 2 years of registration
Who cannot join
- Normal gastric emptying confirmed with scintigraphy
- Diabetic gastroparesis or post-surgical gastroparesis including fundoplication
- Another active disorder which could explain symptoms in the opinion of the investigator
- History of significant cardiac arrhythmias and/or prolonged QTc
- History of seizures
- Use of narcotics more than 3 days per week
Show all 22Show fewer
- Use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6 weeks prior to randomization
- Use of strongly anticholinergic medications
- Use of calcium channel blockers
- Use of erythromycin
- Clear history of failed trial of nortriptyline use for gastroparetic symptoms
- Symptoms of primary depression or suicidal ideation
- Contraindications to nortriptyline:
- hypersensitivity or allergy to any tricyclic antidepressant drug
- concomitant therapy with a monoamine oxidase inhibitor (MAOI)
- recent myocardial infarction
- glaucoma
- Pregnancy or nursing
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
- Use of a G tube, J tube,or a central catheter for nutrition
- Use of a gastric electrical stimulator
- Failure to give informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Temple University Hospital
Philadelphia, Pennsylvania, 19140
California Pacific Medical Center
San Francisco, California, 94115
Stanford University
Stanford, California, 94305-5187
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
- Conditions
- Idiopathic Gastroparesis
- Being tested
- Nortriptyline Hydrochloride, Placebo (for nortriptyline)
- Keywords
- idiopathic gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nortriptyline HydrochlorideDrug
Also called Nortriptyline HCl, Pamelor
Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
Placebo (for nortriptyline)Drug
Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;
| Study group | Role | What they receive |
|---|---|---|
| Nortriptyline | Active comparator | Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg Receives: Drug: Nortriptyline Hydrochloride |
| Placebo (for nortriptyline) | Placebo comparator | No treatment Receives: Drug: Placebo (for nortriptyline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.
Measured: at end of treatment, 15 weeks from baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic GastroparesisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frank Hamilton, MD, MPH, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765895
- Sponsor's protocol ID
- U01DK074008 NORIG
- Other IDs
- 1U01DK073983, 1U01DK073975, 1U01DK073985, 1U01DK074007, 1U01DK073974, 1U01DK074008
- Acronym
- NORIG
- Status last verified
- Apr 2020
- First submitted
- 2 Oct 2008
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/norig/?query=norig
Publications
Parkman HP, Van Natta ML, Abell TL, McCallum RW, Sarosiek I, Nguyen L, Snape WJ, Koch KL, Hasler WL, Farrugia G, Lee L, Unalp-Arida A, Tonascia J, Hamilton F, Pasricha PJ. Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial. JAMA. 2013 Dec 25;310(24):2640-9. doi: 10.1001/jama.2013.282833.
PubMed 24368464
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
- ClinicalTrials.gov ID
- NCT00765895
- Acronym / sponsor ID
- NORIG / U01DK074008 NORIG
- Conditions
- Idiopathic Gastroparesis
- Keywords
- idiopathic gastroparesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jan 2009 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 16 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nortriptyline | Active comparator | Drug: Nortriptyline HydrochlorideNortriptyline Hydrochloride dose escalation from 10 mg to 75 mg |
| Placebo (for nortriptyline) | Placebo comparator | Drug: Placebo (for nortriptyline)No treatment |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 through 65 years old at registration
- Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
- Symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or greater
- Negative upper endoscopy or upper GI series within 2 years of registration
Key exclusion criteria (22 listed)
- Normal gastric emptying confirmed with scintigraphy
- Diabetic gastroparesis or post-surgical gastroparesis including fundoplication
- Another active disorder which could explain symptoms in the opinion of the investigator
- History of significant cardiac arrhythmias and/or prolonged QTc
- History of seizures
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 |
|---|---|---|
| Nortriptyline HydrochlorideAlso: Nortriptyline HCl, PamelorNortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week | Drug | Nortriptyline |
| Placebo (for nortriptyline)Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; | Drug | Placebo (for nortriptyline) |
Primary outcome
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
Time frame: at end of treatment, 15 weeks from baseline assessment
A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24368464Parkman HP, Van Natta ML, Abell TL, McCallum RW, Sarosiek I, Nguyen L, Snape WJ, Koch KL, Hasler WL, Farrugia G, Lee L, Unalp-Arida A, Tonascia J, Hamilton F, Pasricha PJ. Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial. JAMA. 2013 Dec 25;310(24):2640-9. doi: 10.1001/jama.2013.282833.
- Click here for information on gastroparesis researchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/norig/?query=norig
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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.
Frank Hamilton, MD, MPH study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
7 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 Nortriptyline Hydrochloride in people with Idiopathic Gastroparesis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 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 4 inclusion and 22 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Yes. Results are posted in the registry (first posted 16 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (time frame: at end of treatment, 15 weeks from baseline assessment). 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 NCT00765895, 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 14 May 2020.