Trial · NCT02707640
A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT02707640, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT02707640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02707640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
- NCT number
- NCT02707640
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Matching Placebo, N-acetylcysteine, Pirfenidone
- First posted
- 2016-03-14
- Last updated
- 2016-05-20
- Other registries' IDs
- eudract:2012-000564-14
- Results first posted
- 2016-05-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Dose Reductions | From baseline up to 24 weeks | Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period. |
| Primary | Percentage of Participants With Early Treatment Discontinuations | From baseline up to 24 weeks | Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period. |
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Until 28 days from last dose of study treatment (Week 28) | An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. |
| Primary | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Until 28 days from last dose of study treatment (Week 28) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. |
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment | Until 28 days from last dose of study treatment (Week 28) | |
| Primary | Percentage of Participants With Treatment-Emergent Deaths of All Causes | Until 28 days from last dose of study treatment (Week 28) | |
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment | Until 28 days from last dose of study treatment (Week 28) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Dose Reductions | From baseline up to 24 weeks | mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Early Treatment Discontinuations | From baseline up to 24 weeks | mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Until 28 days from last dose of study treatment (Week 28) | mITT Population included participants who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Until 28 days from last dose of study treatment (Week 28) | mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment | Until 28 days from last dose of study treatment (Week 28) | mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Deaths of All Causes | Until 28 days from last dose of study treatment (Week 28) | mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment | Until 28 days from last dose of study treatment (Week 28) | mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo). | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Dose Reductions | N-Acetylcysteine (NAC) | 5 | percentage of participants | ||
| Percentage of Participants With Dose Reductions | Placebo | 4.8 | percentage of participants | ||
| Percentage of Participants With Early Treatment Discontinuations | N-Acetylcysteine (NAC) | 14.8 | percentage of participants | ||
| Percentage of Participants With Early Treatment Discontinuations | Placebo | 11.3 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | N-Acetylcysteine (NAC) | 76.7 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | 80.6 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | N-Acetylcysteine (NAC) | 5.0 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Placebo | 6.5 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment | N-Acetylcysteine (NAC) | 6.7 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment | Placebo | 1.6 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-Acetylcysteine (NAC) | 61 | |
| Overall Study | STARTED | Placebo | 62 | |
| Overall Study | COMPLETED | N-Acetylcysteine (NAC) | 52 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | NOT COMPLETED | N-Acetylcysteine (NAC) | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | N-Acetylcysteine (NAC) | 4 | 60 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo | 0 | 62 | |
| other | DIARRHOEA | Gastrointestinal disorders | N-Acetylcysteine (NAC) | 6 | 60 | |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 9 | 62 | |
| other | NAUSEA | Gastrointestinal disorders | N-Acetylcysteine (NAC) | 4 | 60 | |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 5 | 62 | |
| other | BRONCHITIS | Infections and infestations | N-Acetylcysteine (NAC) | 4 | 60 | |
| other | BRONCHITIS | Infections and infestations | Placebo | 3 | 62 | |
| other | INFLUENZA | Infections and infestations | N-Acetylcysteine (NAC) | 3 | 60 | |
| other | INFLUENZA | Infections and infestations | Placebo | 1 | 62 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-Acetylcysteine (NAC) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | N-Acetylcysteine (NAC) | 46 | 60 |
| Total, other adverse events | Placebo | 50 | 62 |
| Total, serious adverse events | N-Acetylcysteine (NAC) | 3 | 60 |
| Total, serious adverse events | Placebo | 4 | 62 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| N-Acetylcysteine (NAC) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02707640
GET https://conductscience.org/api/trials/v1/NCT02707640/events?page=2