A Phase 3 interventional study of MAX-002 and Placebo in Proctitis, Ulcerative, sponsored by Forest Laboratories. Terminated at 40 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Forest Laboratories (part of AbbVie) · Phase 3, Interventional, and Treatment
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).
The present study consists of screening period (2 weeks before randomization), DB phase (6 weeks), OL phase (8 weeks) and follow-up visits at Week 3, Week 6 and Week 14. Participants who are eligible will be randomized to receive 1g MAX-002, 1g Canasa® and placebo suppository once daily in the DB phase. Participants who complete or discontinue the study at Week 6 will either receive 1g MAX-002 suppositories on a voluntary basis, standard care treatment as per investigator's discretion or no treatment during the next 8 weeks of the OL phase. Total duration of treatment will be of 14 weeks. Efficacy will primarily be evaluated by percentage of participants who show response as per Mayo DAI Score at Week 6. Participants' safety will be monitored throughout the study.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
This study's enrollment of 119 is close to the median of 122 across 23 interventional studies indexed under Proctitis.
Browse Proctitis studies →Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
First submitted before Forest Laboratories became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MAX-002
Drug: Placebo
Drug: Canasa®
MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase.
Also known as: Mesalamine
Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Also known as: Mesalamine
Percentage of Participants Who Were Responders at Week 6
Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Time frame: Week 6
Percentage of Participants Who Were Responders at Week 3
Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Time frame: Week 3
Time to Relief of Rectal Bleeding
Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.
Time frame: Day 1 up to Week 6
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.
Time frame: Baseline, Week 6
Time to Relief of Tenesmus
Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.
Time frame: Day 1 up to Week 6
| Milestone | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) | MAX-002 (Open-label Phase) | Standard Care Treatment (Open-label Phase) | No Treatment (Open-label Phase) |
|---|---|---|---|---|---|---|
| Started | 41 | 39 | 39 | 0 | 0 | 0 |
| Completed | 40 | 38 | 30 | 0 | 0 | 0 |
| Not completed | 1 | 1 | 9 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 5 | 0 | 0 | 0 |
| Withdrew: Disease progression | 0 | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal of informed consent | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) | MAX-002 (Open-label Phase) | Standard Care Treatment (Open-label Phase) | No Treatment (Open-label Phase) |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 44 | 52 | 20 |
| Completed | 0 | 0 | 0 | 42 | 50 | 20 |
| Not completed | 0 | 0 | 0 | 2 | 2 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal of informed consent | 0 | 0 | 0 | 0 | 1 | 0 |
Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
| percentage of participants | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) |
|---|---|---|---|
| Percentage of Participants Who Were Responders at Week 6 | 56.1 | 46.2 | 23.1 |
Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
| percentage of participants | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) |
|---|---|---|---|
| Percentage of Participants Who Were Responders at Week 3 | 36.6 | 38.5 | 12.8 |
Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.
| days | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) |
|---|---|---|---|
| Time to Relief of Rectal Bleeding | 6 (4 to 9) | 5 (3 to 12) | 21 (7 to NA) |
The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.
| units on a scale | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) |
|---|---|---|---|
| Baseline (n= 41, 39, 39) | 153.45 ± 35.03 | 153.19 ± 38.75 | 149.18 ± 32.40 |
| Change at Week 6 (n= 41, 39, 31) | 30.59 ± 28.95 | 42.42 ± 31.26 | 24.48 ± 27.29 |
Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.
| days | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) |
|---|---|---|---|
| Time to Relief of Tenesmus | 3 (1 to 4) | 2 (1 to 5) | 1 (1 to 10) |
Collected over Baseline up to end of study (Week 14). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MAX-002 (Double-blind Phase) | 0/40 (0%) | 0/40 (0%) | 14/40 (35%) |
| Canasa® (Double-blind Phase) | 0/41 (0%) | 1/41 (2.4%) | 16/41 (39%) |
| Placebo (Double-blind Phase) | 0/38 (0%) | 0/38 (0%) | 20/38 (52.6%) |
| MAX-002 (Open-label Phase) | 0/44 (0%) | 1/44 (2.3%) | 20/44 (45.5%) |
| Standard Care Treatment (Open-label Phase) | 0/52 (0%) | 0/52 (0%) | 20/52 (38.5%) |
| No Treatment (Open-label Phase) | 0/20 (0%) | 0/20 (0%) | 9/20 (45%) |
| Event | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) | MAX-002 (Open-label Phase) | Standard Care Treatment (Open-label Phase) | No Treatment (Open-label Phase) |
|---|---|---|---|---|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 0/40 | 1/41 | 0/38 | 0/44 | 0/52 | 0/20 |
| Non-cardiac chest painGeneral disorders | 0/40 | 0/41 | 0/38 | 1/44 | 0/52 | 0/20 |
| Event | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) | MAX-002 (Open-label Phase) | Standard Care Treatment (Open-label Phase) | No Treatment (Open-label Phase) |
|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 3/40 | 6/41 | 6/38 | 3/44 | 2/52 | 3/20 |
| Abdominal painGastrointestinal disorders | 2/40 | 0/41 | 4/38 | 3/44 | 2/52 | 0/20 |
| NauseaGastrointestinal disorders | 1/40 | 1/41 | 4/38 | 0/44 | 0/52 | 0/20 |
| NasopharyngitisInfections and infestations | 1/40 | 2/41 | 3/38 | 3/44 | 3/52 | 2/20 |
| Anorectal discomfortGastrointestinal disorders | 1/40 | 0/41 | 2/38 | 1/44 | 0/52 | 0/20 |
| ToothacheGastrointestinal disorders | 2/40 | 0/41 | 0/38 | 0/44 | 1/52 | 0/20 |
| Rectal haemorrhageGastrointestinal disorders | 0/40 | 0/41 | 1/38 | 0/44 | 0/52 | 1/20 |
| Influenza like illnessGeneral disorders | 0/40 | 0/41 | 0/38 | 1/44 | 0/52 | 1/20 |
| PharyngitisInfections and infestations | 1/40 | 0/41 | 0/38 | 0/44 | 2/52 | 1/20 |
| TendonitisMusculoskeletal and connective tissue disorders | 0/40 | 0/41 | 0/38 | 0/44 | 0/52 | 1/20 |
Intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(years) | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) | Total |
|---|---|---|---|---|
| Mean | 44.3 ± 13.55 | 44.8 ± 11.70 | 41.8 ± 12.84 | 43.7 ± 12.69 |
| Sex: Female, Male(Participants) | MAX-002 (Double-blind Phase) | Canasa® (Double-blind Phase) | Placebo (Double-blind Phase) | Total |
|---|---|---|---|---|
| Female | 19 | 19 | 23 | 61 |
| Male | 22 | 20 | 16 | 58 |
Ran from Nov 2009 to primary completion in Jul 2011, 20 months.
Results were first posted in Aug 2019, 8 years after primary completion.
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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesalamine